- A Multicenter, Open-Label, Randomized Trial to Evaluate the Anti-Cancer Effects of Zoledronic Acid Using Circulating Tumor Cell Measurements in Patients with Newly Diagnosed HER2-Negative Metastatic Breast Cancer
- A Randomized Double-blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women With Early-Stage HER-2/neu Overexpressed/Amplified Breast Cancer
- Inamed Style 410 Silicone-Filled Breast Implant, Reconstruction/Revision Expansion CARE Clinical Study
The Food and Drug Administration (FDA) has issued a guidance document requiring that clinical studies be conducted to establish the safety and efficacy of silicone-filled breast implants (“Guidance on Preclinical and Clinical Data and Labeling for Breast Prosthesis”, January 13, 2004). The Inamed Style 410 Silicone-Filled Breast Implant is an experimental device that is available to patients who participate in this clinical study. This study is designed to provide access to a shaped, silicone-filled implant to reconstruction and revision patients and to provide additional information to the Style 410 IDE regarding the safety and effectiveness of Inamed Style 410 Silicone-Filled Breast Implants in women undergoing breast implant reconstruction or revision surgery.
- LPT 112515 - A Randomized, Phase III, Open-label, Study of Lapatinib plus Trastuzumab versus Trastuzumab as Continued HER2 Suppression Therapy after Completion of First or Second Line Trastuzumab plus Chemotherapy in Subjects with HER2 Positive Metastatic Breast Cancer.
PURPOSE: This is a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible subjects will have completed 12 to 24 weeks of first- or second-line treatment with trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic lesions or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions, and been indicated to continue to receive trastuzumab alone as maintenance therapy. Eligible subjects also will not have a known history of CNS (central nervous system) metastases. The primary objective of this study is to compare progression-free survival (PFS) in subjects with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus those randomized to receive trastuzumab alone. The secondary objectives include overall survival, clinical benefit response rate (complete response [CR], partial response [PR] or stable disease [SD] =24 weeks) and the qualitative and quantitative adverse event profile of the 2 treatment arms. It is estimated that 276 subjects (138 per group) will be required to observe 192 PFS events. (NCT0096896)
- NSABP - B-43 - A Phase III Clinical Trial Comparing Trastuzamab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with Her2-Positive Ductal Carcinoma in Situ Resected by Lumpectomy.
Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ. This randomized phase III trial is studying radiation therapy to see how well it works compared with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. (NCT00769379)
- NSABP B-47 – A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women with Node-Positive or High-Risk Node Negative HER2-Low Invasive Breast Cancer.
Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving chemotherapy after surgery may kill more tumor cells. Monoclonal antibodies, such as trastuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known whether combination chemotherapy is more effective with trastuzumab in treating breast cancer. This randomized phase III clinical trial is studying chemotherapy with or without trastuzumab after surgery to see how well they work in treating women with invasive breast cancer. (NCT01275677)
- NSABP B-49 - A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer.
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different combinations may kill more breast cancer cells. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens and their side effects and comparing how well they work in treating women with non-metastatic breast cancer. (NCT01547741)
- RTOG 1005 - A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer.
RATIONALE: Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether high-dose radiation therapy is more effective than standard radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well high-dose radiation therapy works compared to standard radiation therapy in treating patients with early-stage breast cancer that was removed by surgery. (NCT 01349322)
- RTOG 1014 - Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery. (NCT01082211)
- RTOG 1014 - Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery. (NCT01082211)
