Breast
The following list provides a brief description of breast cancer trials that are open for recruitment in Western Australia. If you would like more information please follow the links provided, contact one of the trial sites or speak with your doctor.
Please note that this list is based on information provided to the Cancer Council by WA hospitals and may not include all clinical trials that are running in WA.
Where ‘N/A' appears - this means the lacking information has not been provided to date to the Cancer Council.
APHINITY Study
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Registered Title |
A Randomized Multicenter, Double-blind, Placebo-controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-positive Primary Breast Cancer. |
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Purpose |
This randomized, double-blind, placebo-controlled, two-arm study will assess the safety and efficacy of pertuzumab in addition to chemotherapy plus Herceptin (trastuzumab) as adjuvant therapy in patients with operable HER2-positive primary breast cancer. After surgery, patients will be randomized to receive either pertuzumab or placebo intravenously (iv) every 3 weeks for one year, in addition to 6-8 cycles of chemotherapy and 1 year of Herceptin (trastuzumab) iv every 3 weeks. Anticipated time on study treatment is 52 weeks. |
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Lay Summary |
N/A |
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WA Trial Sites |
SCGH Medical Oncology |
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Links |
Acknowledgements: US National Library of Medicine.
ANZ 0501 LATER
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Registered Title |
Later adjuvant Aromatase inhibitor Therapy for postmenopausal women with Endocrine Responsive breast cancer (LATER). A Phase III randomised double blind trial in postmenopausal women who have completed 5 years of adjuvant endocrine therapy for early, hormone sensitive breast cancer more than one (1) year previous, and who are disease-free at study entry. |
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Purpose |
The major concern for women on long term follow up after breast cancer has been treated, is fear of the reoccurrence of disease. This study will test a new strategy to prevent disease reoccurrence and death due to breast cancer. The purpose of the study is to find out whether later re-treatment of participants with adjuvant letrozole therapy can prevent or delay new breast cancers from reoccurring in postmenopausal women previously treated with adjuvant endocrine therapy. |
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Lay Summary |
Letrozole is a hormone tablet that reduces the risk of future breast cancer problems in postmenopausal women if they start it within 6 months of completing 5 years of tamoxifen (a type of hormone therapy). This international randomized trial will determine if women who completed their 5 years of tamoxifen more than 12 months ago can also benefit from letrozole to prevent the re-occurrence of breast cancer. |
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WA Trial Sites |
SCGH Breast Centre
RPH Medical Oncology |
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Links |
Acknowledgements: Australian New Zealand Clinical Trials Registry, The Cancer Council NSW
BAY43 Study
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Registered Title |
A Phase III Randomized, Double‐blind, Placebo‐controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2‐Negative Breast Cancer. |
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Purpose |
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not recommended. |
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Lay Summary |
N/A |
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WA Trial Sites |
The Mount Hospital |
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Links |
Acknowledgements: US National Library of Medicine
BOLERO3 Study
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Registered Title |
A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer. |
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Purpose |
This phase III, double-blind, placebo-controlled multinational study will assess the combination everolimus, vinorelbine, and trastuzumab compared to the combination vinorelbine and trastuzumab with respect to progressive-free survival and over survival in HER2/neu positive women with locally advanced or metastatic breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane. |
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Lay Summary |
N/A |
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WA Trial Sites |
St John of God |
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Links |
Acknowledgements: US National Library of Medicine
CATS Study
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Registered Title |
Predicion of cardiotoxicity using serum N-terminal pro-B-type natriuretic peptide in breast cancer patients receiving adjuvant trastuzumab. |
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Purpose |
Trastuzumab (Herceptin®) increases the chances of cure in patients with Her-2 overexpressing early breast cancer. Unfortunately, both the chemotherapy drugs used in this setting (anthracyclines) and trastuzumab are known to cause cardiac dysfunction in a proportion of patients. Patients who develop heart problems when taking trastuzumab might have to stop this treatment, which could jeopardise their chances of cure. N-terminal pro-B-type natriuretic peptide (NT pro-BNP) is a cardiac biomarker that is measured in the blood, the levels of which have been shown to indicate the presence of heart failure. Some early research has suggested that there may be a correlation between elevated NT pro-BNP and heart damage due to cancer chemotherapy and also trastuzumab. |
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Lay Summary |
N/A |
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WA Trial Sites |
The Mount Hospital |
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Link |
Acknowledgements: US National Library of Medicine
D-Care study
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Registered Title |
A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE). |
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Purpose |
The purpose of this study is to evaluate the ability of denosumab to prolong BMFS (bone metastasis free survival) and disease free survival (DFS) in breast cancer patients at high risk for disease recurrence, when combined with standard of care adjuvant/ neoadjuvant cancer therapy. |
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Lay Summary |
Completion of this trial will address whether treatment with Denosumab delays development of first bone metastasis, improves disease free survival and/or improves overall survival, when compared to placebo. If Denosumab is found to be beneficial, this could improve the outcome for many women with stage II or III breast cancer. |
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WA Trial Sites |
The Mount Hospital
St John of God |
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Links |
Acknowledgements: US National Library of Medicine
Goserelin (Zoladex) Study
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Registered Title |
Evaluative Study of Quality of Life in pre-menopausal women with low-risk early breast cancer (Goserelin Study). |
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Purpose |
This is a prospective study looking at treatment preferences, decision making, decision regret, patient preferences, side effects and disease outcome in pre-menopausal women under 45 years with low-risk early breast cancer. |
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Lay Summary |
This evaluative study aims to collect detailed information on treatment choices and preferences of pre-menopausal women under 45 years with low-risk early breast cancer to determine patient preferences and decisional conflict and regret in low risk young breast cancer patients regarding adjuvant systemic treatment with goserelin (with or without Tamoxifen) or chemotherapy (with or without Tamoxifen). Recruitment is over 24-months at multiple sites in Australia and patients with "low risk" breast cancer will be invited to participate after they have chosen their treatment. Treatment arms include:
A total of 150 participants will be recruited to account for potential drop-out during the study. |
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WA Trial Sites |
SCGH Breast Centre |
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Links |
Acknowledgements: Australia New Zealand Clinical Trials Registry
IBIS II DCIS
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Registered Title |
An international multi-centre study of tamoxifen vs. anastrozole in postmenopausal women with hormone sensitive Ductal Carcinoma In Situ (DCIS). |
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Purpose |
The purpose of the IBIS II DCIS study is to find out whether anastrozole is as effective or better than tamoxifen in preventing the development of breast cancer in the same breast as the DCIS or in the opposite breast, in postmenopausal women who have been diagnosed with DCIS within the last 6 months. The study will also compare the effects (good and bad) of tamoxifen and anastrozole. |
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Lay Summary |
Invasive breast cancer (which means that the cancer cells have spread outside of the breast ducts) has been successfully treated for many years with hormonal drugs such as tamoxifen and anastrozole. These drugs reduce the amount of oestrogen in the body (oestrogen is one of the female hormones), and this has been shown to have a beneficial effect in women with certain types of breast cancer. In some women, the drugs can prevent the breast cancer returning and new breast cancers forming in the opposite breast.
In recent clinical trials women with DCIS have been given tamoxifen, and results show a reduction in the number of women whose DCIS progressed into invasive breast cancer. However, further research is needed to determine the particular group of women with DCIS who will benefit from taking tamoxifen. |
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WA Trial Sites |
SCGH Radiation Oncology |
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Links |
JUST study
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Registered Title |
Phase II randomised, placebo-controlled study to evaluate the efficacy of topical pure emu oil for arthralgic pain related to aromatase inhibitor use in postmenopausal women with early breast cancer: JUST Joints Under Study. |
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Purpose |
A common side effect of aromatase inhibitor use is joint pain and stiffness. As aromatase inhibitor drugs provide better protection against breast cancer recurrence, it is important to help women tolerate the side effects of the drug so that they can complete the 3 to 5 years of therapy. |
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Lay Summary |
Hormonal drugs called anastrozole or letrozole are in the family of drugs called aromatase inhibitors. The aim of this study is to find out whether the use of emu oil rubbed into painful joints on a daily basis, can lessen the pain in joints when used over an 8 to 16 week period. |
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WA Trial Sites |
Mount Hospital |
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Links |
N/A |
Mammographic Density Study
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Registered Title |
Histopathological, Magnetic Resonance (MR) and Ultrasound correlates of Mammographic Density in BRCA1/2 Mutation Carriers |
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Purpose |
The underlying histopathological correlates of MD are poorly understood and should inform further our understanding of breast cancer pathogenesis, and help to suggest novel breast cancer risk reduction strategies, particularly for BRCA1/2 mutation carriers. Understanding the correlation between MD and breast MRI and ultrasound appearances should help with the clinical interpretation of breast MR images, and improve the utility of breast MRI when it is used as a breast cancer screening tool. |
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Lay Summary |
Assessment of Mammographic Density in Women at High Risk of Developing Breast Cancer.
Mammographic density is measured by the amount of white changes seen on a mammogram. These white changes are strongly related to the risk of developing breast cancer. The greater the extent of mammographic density (MD), the greater the risk of developing breast cancer.
The exact type of breast tissue underlying the white changes that are mammographic density is poorly understood, but this research study hopes to better determine the nature of this breast tissue. We are also interested on how this tissue looks on MRI (magnetic resonance imaging - a new but very accurate way to screen women at high risk of breast cancer) and breast ultrasound. Improving our understanding may in turn provide us with new insights into why breast cancer develops and point to new directions for breast cancer screening and treatments.
The research team will recruit 200 Australian women who are known carriers for one or more gene mutations (or faulty genes) which put them at a high risk of developing breast cancer. Researchers hope to gain a better understanding of the type of breast tissue associated with MD and to determine the corresponding breast MRI and ultrasound features associated with MD in this group of women. One part of the study will also collect blood from the participating women for future research into a genetic basis of MD.
For each participant, a member of the research team will review the woman's most recent screening mammogram and breast MR images. An experienced Radiologist will also take a small breast tissue sample (under local anaesthetic) and a blood sample to be analysed by the research team.
The information and samples we gather from participants will be safely stored at the Peter MacCallum Tissue Bank. The central tissue bank will hold all information securely and will not release it to any individual or organisation outside of the study. |
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WA Trial Sites |
RPH Medical Oncology (Breast Clinic) |
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Links |
N/A |
Non-Randomised IORT
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Registered Title |
Prospective Non-randomised Intrabeam Protocol. |
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Purpose |
The main purpose of this study is to offer a once off dose of intraoperative radiotherapy to women with early breast cancer, who are either over the age of 70 or have a medical or social reason for not being able to have a 5-6-week course of standard external beam radiotherapy. Intraoperative radiotherapy is not yet a standard form of treatment (it is still experimental) because although early results suggest it is as good as standard treatment for a specific group of women, information about the potential longer term effects of the treatment is not yet known. As a result, women can only have this treatment as part of a formal clinical trial. |
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Lay Summary |
It has been clearly shown that in early low-risk breast cancer, removal of only the tumour and the lymph nodes under the armpit followed by post-operative radiotherapy is effective and has the benefit of preserving the breast. This type of treatment is called breast conserving therapy. Traditionally, radiotherapy is given daily for 5-6 weeks (Monday to Friday). Intra-operative Radiotherapy, a new form of radiation therapy, has now become available for patients suitable for breast conserving therapy. The new technique involves the delivery of radiation intra-operatively (during surgery) in a single procedure. The safety and feasibility of this new device has been tested internationally, and since this treatment is not yet considered standard therapy, this trial allows women to receive the treatment if found suitable by a Radiation Oncologist. |
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WA Trial Sites |
SCGH Radiation Oncology |
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Links |
N/A |
Pharmacogenetics Study Breast / Lung
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Registered Title |
The Effect of Pharmacogenetics on Treatment Toxicities and Outcomes in East Asian and Caucasian Patients Undergoing Docetaxel or Gemcitabine-Based Chemotherapy. |
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Purpose |
Germ line polymorphisms are inherited genetic variations present in all cells of the body. Mounting evidence has shown that genetic polymorphisms in drug metabolizing, transporter and targets genes are major determinants of response to drugs.
To date, most pharmacogenetic strategies are predominantly focused on the role of single genes, in the regulation of drug metabolism. However, there is clear evidence that treatment outcomes are under the control of a network of genes, each contributing to the patient's phenotype. In this study, we propose taking a global approach to include relevant candidate genes in drug pathways to evaluate the effect of polymorphisms and treatment outcomes. We have selected two commonly used chemotherapy regimens based on our previous observation of inter-ethnic variability in treatment outcomes and candidate polymorphisms.
The aims of this study are:
a. treatment toxicity
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Lay Summary |
N/A |
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WA Trial Sites |
SCGH Medical Oncology |
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Links |
Acknowledgements: US National Library of Medicine
SHERsig Study
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Registered Title |
A prospective Phase II study to evaluate alterations in molecular biomarkers in HER2-positive metastatic breat cancer together with assessment of trastuzumab use beyond progression after initial exposure to trastuzumab-taxane based treatment. |
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Purpose |
This single arm study will evaluate alterations in molecular marker expression in HER2-positive targeted therapy, and will evaluate the effect of continued treatment with Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy. Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda (1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken for biomarker and gene profiling evaluation. The anticipated time on study treatment is until disease progression, intolerable side effects or patient choice, and the target sample size is 100 individuals. |
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Lay Summary |
N/A |
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WA Trial Sites |
Mount Hospital
RPH Medical Oncology |
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Links |
Acknowledgements: US National Library of Medicine
SOLE
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Registered Title |
A phase III trial evaluating the role of continuous letrozole versus intermittent letrozole following 4 to 6 years of prior adjuvant endocrine therapy for postmenopausal women with hormone-receptor positive, node positive early stage breast cancer. |
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Purpose |
Oestrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of oestrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer.
This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer. |
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Lay Summary |
There is evidence confirming that hormonal treatment with drugs known as aromatase inhibitors (like letrozole) is effective in preventing breast cancer from returning. However, the optimal duration or schedule for this treatment is not currently known. 4800 patients who have already completed 4-6 years of hormonal treatment will take part in SOLE, an international randomised clinical trial, and will receive hormonal treatment with the drug letrozole for a further 5 years. This trial will determine if introducing a treatment gap of 3 months every year, for 5 years has any benefit over continuous treatment for 5 years.** |
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WA Trial Sites |
RPH Medical Oncology |
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Links |
Australian New Zealand Clinical Trials Registry |
Acknowledgements: US National Library of Medicine. **Australian New Zealand Breast Cancer Trials Group
Sorbet Trial
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Registered Title |
A Single Arm Phase II Study of the Efficacy of Tamoxifen in Triple Negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) but Oestrogen Receptor Beta Positive Metastatic Breast Cancer. |
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Purpose |
This study looks at the effectiveness of the drug tamoxifen in treating breast cancer which is classified as triple negative (oestrogen receptor alpha negative, progesterone receptor negative, HER-2 negative) and oestrogen receptor beta positive, where the cancer has spread to distant sites (metastases). |
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Lay Summary |
Who is it for? You can join this study if you are a woman with triple negative metastatic breast cancer that is oestrogen receptor beta positive and chemotherapy and/or radiotherapy is currently not considered appropriate. Prior to entering the study, a sample of metastatic tumour must be tested and confirmed to be oestrogen receptor beta positive.
Trial details Some breast cancer cells contain receptors which the female hormone oestrogen binds to, causing the cancer to grow. The study aims to find out whether tamoxifen may be useful for treating metastatic breast cancer that contains the oestrogen beta receptor. Tamoxifen is an anti-oestrogen drug which is frequently used to treat breast cancers that contain the oestrogen alpha receptor but has not been used specifically to treat breast cancers that contain the oestrogen beta receptor.
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WA Trial Sites |
SCGH Medical Oncology |
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Links |
Acknowledgements: Australia New Zealand Clinical Trials Registry
STARS (TROG 08.06)
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Registered Title |
A randomised comparison of anastrozole commenced before and continued during adjuvant radiotherapy for breast cancer versus anastrozole and subsequent anti-oestrogen therapy delayed until after radiotherapy. (STARS - Study of Anastrozole and Radiotherapy Sequencing). |
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Purpose |
The primary objective of the study is to determine if commencement of anastrozole prior to radiotherapy results in improved local control compared to anastrozole commenced after radiotherapy. Post-irradiation initiation of anastrozole is considered to be the standard arm.
Secondary objectives will be an examination of rates of distant failure, overall survival, normal tissue complications and cosmetic outcomes after radiation. |
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Lay Summary |
Who is it for? You can join this study if you are a woman who has had a mastectomy or lumpectomy for breast cancer, and all planned surgery is now complete.
Trial details Participants will be divided into two groups. One group will receive anastrozole orally before and during radiotherapy. The other group will receive standard treatment, where anastrozole and subsequent anti-oestrogen therapy is delayed until after radiotherapy. Participants will be monitored for 10 years after radiotherapy. The study aims to determine if commencement of anastrozole before radiotherapy results in improved local control of the disease. |
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WA Trial Sites |
Perth Radiation Oncology Centre |
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Links |
US National Library of Medicine |
SUPREMO TRIAL (TROG 11.3)
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Registered Title |
SUPREMO (Selective Use of Postoperative Radiotherapy AftEr MastectOmy). |
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Purpose |
To Investigate the effect of postoperative radiotherapy on:
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Lay Summary |
There exists international consensus in support of chest wall irradiation for women deemed as ‘higher risk' of local regional recurrence after mastectomy and systemic therapy. Literature suggests post-mastectomy radiotherapy reduces breast cancer mortality in women with a risk of local-regional recurrence by five percent. The researchers claim that if this is the case, then women at "intermediate risk" may also benefit from radiotherapy to the chest wall post mastectomy and systemic therapy.
The benefit of chest wall irradiation for women deemed as "intermediate risk" of loco-regional recurrence after mastectomy and systemic therapy is uncertain at present. Thus, the goal of this trial is to see if radiotherapy to the chest wall can help prevent disease recurrence in women at "intermediate risk" of local/regional recurrence. The SUPREMO trial is a randomised control trial and this means that, in addition to standard therapies, half the patients in the trial will receive radiotherapy to the chest wall and half will not receive radiotherapy to the chest wall. |
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WA Trial Sites |
SCGH Radiation Oncology |
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Links |
TARGIT
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Registered Title |
A Randomised Controlled Trial of Intra-Operative Radiotherapy vs Conventional Radiotherapy for Grade I-II ('low-risk') Breast Cancer. |
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Purpose |
The main purpose of this study is to identify whether or not offering intra-operative radiotherapy (IORT) alone is as effective as the conventional 5-6-week course of external radiotherapy. If it is as effective, it could mean a big saving in time for patients who would have had to travel to the hospital every day for daily treatments over 5-6 weeks, especially country patients who usually relocate to Perth for those weeks. Having less external radiotherapy may also lead to less skin-related effects associated with external radiotherapy and possibly a better cosmetic outcome. Women joining this trial will have a 50% chance of being randomly allocated IORT and a 50% chance of being randomly allocated external beam radiotherapy. |
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Lay Summary |
It has been clearly shown that in early low-risk breast cancer, removal of only the tumour and the lymph nodes under the armpit followed by post-operative radiotherapy is effective and has the benefit of preserving the breast. This type of treatment is called breast conserving therapy.Traditionally, radiotherapy is given daily for 5-6 weeks (Monday to Friday). Intra-operative Radiotherapy, a new form of radiation therapy, has now become available for patients suitable for breast conserving therapy. The new technique involves the delivery of radiation intra-operatively (during surgery) in a single procedure. The safety and feasibility of this new device has been tested internationally, and this trial will test whether it is as effective as conventional treatment in terms of the risk of the cancer returning to the same area of the same breast. Early results suggest that intraoperative radiotherapy is as good as traditional external radiotherapy, however longer term follow-up of patients is on-going. |
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WA Trial Sites |
Breast Centre & Radiation Oncology SCGH
Breast Centre & Radiation Oncology RPH
Perth Radiation Oncology Centre |
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Links |
TRIO-012 Study
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Registered Title |
A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of Ramucirumab (IMC-1121B) Plus Docetaxel versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer. |
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Purpose |
The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer. |
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Lay Summary |
N/A |
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WA Trial Sites |
RPH Medical Oncology |
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Links |
Acknowledgements: US National Library of Medicine
TROG 07.01 DCIS Study
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Registered Title |
A randomised phase III study of radiation doses and fractionation schedules in non-low risk ductal carcinoma in situ (DCIS) of the breast. |
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Purpose |
The purpose of the study is threefold:
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Lay Summary |
DCIS is an abnormality of the breast that has a high predisposition to develop into breast cancer. The usual treatment is surgery to remove the abnormal tissue from the breast. Radiation therapy after breast surgery can reduce the risk of subsequent cancers developing in and around the tumor bed. This randomized trial will look at which treatment regimen, 5-7 week course or 4-5 week course, of radiotherapy will be of most benefit to women that fit this criteria. |
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WA Trial Sites |
SCGH Radiation Oncology
Perth Radiation Oncology Centre |
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Links |
US National Library of Medicine |
TyN: Tykerb and Vinorelbine study
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Registered Title |
Phase II open label trial of lapatinib and vinorelbine in women with previously treated her2/neu positive metastatic breast cancer. |
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Purpose |
To evaluate the progression-free survival (PFS) in subjects with Her2/neu positive metastatic breast cancer treated with lapatinib and vinorelbine following trastuzumab-based therapy and lapatinib and capecitabine. Subjects with measurable or non-measurable but evaluable metastatic disease which over-expresses Her2/neu as defined by ISH positivity by local laboratory evaluation and whose disease has progressed after initial exposure to trastuzumab-based treatment followed by lapatinib-capecitabine in the metastatic setting will be eligible to enter. |
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Lay Summary |
The current best standard treatment for women with HER2/neu positive metastatic breast cancer is herceptin with chemotherapy initially. If the cancer grows despite this treatment, the next standard treatment is usually tykerb and chemotherapy. However, if cancer grows again after these two treatment, there is currently no other proven treatment which will slow down the cancer's growth. The aim of this study is to use a new combination of treatment with tykerb and vinorelbine, in an attempt to slow down and shrink your cancer's growth. |
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WA Trial Sites |
The Mount Hospital
RPH Medical Oncology |
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Links |
N/A |
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