Breast Cancer Clinical Trials

If you are an interested patient, researcher or sponsor, please feel free to call us at (845) 483-6825 or email research@health-quest.org.

Open to Enrollment

Study Identifier: Alliance A011202 

Study Title: Comparison of Axillary Lymph Node Dissection with Axillary Radiation for Patients with Node-Positive Breast Cancer Treated with Chemotherapy
Type of Breast Cancer: Breast cancer that has spread to the lymph nodes located in the armpit.

Study Summary: The purpose of the A011202 study is to examine whether removing some of the sentinel lymph nodes, but not removing them all followed with radiation therapy (experimental, new and currently being studied) will be as good as having the majority of sentinel lymph nodes removed during breast surgery followed with radiation (standard of care). Patients with this type of breast cancer usually have neoadjuvant (which means "given before surgery") chemotherapy followed by breast and armpit surgery to remove any remaining breast cancer. The lymph nodes in the armpit are examined during surgery and if there is still cancer in the lymph nodes, then the majority of lymph nodes in the arm pit are removed. This study is being carried out to evaluate treatment options for breast cancer that has spread to the lymph nodes. 


Study Identifier: Alliance A011104 

Study Title: MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer

Study Summary: The purpose of this study is to test whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves our ability to evaluate tumors and decide what kind of surgery is best for the patient.

Study Type: Interventional Phase 3


Study Identifier: NSABP B-51

Study Title: Standard or Comprehensive Radiation Therapy in Treating Patients with Early-Stage Breast Cancer Previously Treated with Chemotherapy and Surgery
Type of Breast Cancer: Breast cancer with no cancer cells in the lymph nodes, known as negative axillary nodes 

Study Summary: The B-51 study is being done to study women with breast cancer, who had cancer cells in the lymph nodes at the time of initial diagnosis, then chemotherapy and surgery, at which time the cancer cells in the lymph nodes cleared. This study is trying to determine for those women, if a lumpectomy or mastectomy and then radiation to the breast or to where the breast used to be and lymph nodes, will be better than radiation only to the breast at keeping breast cancer from returning.


Study Identifier: NSABP B-59

Principal Investigator: Radhika Rachamalla, MD

Study Title: Clinical Trial of Neoadjuvant Chemotherapy With Atezolizumab or Placebo in Patients With Triple-Negative Breast Cancer Followed After Surgery by Atezolizumab or Placebo

Study Summary: The main purpose of this study is to learn if the usual chemotherapy given before surgery (neoadjuvant therapy) for breast cancer plus the experimental drug, atezolizumab, is better than the usual chemotherapy plus a placebo. (A placebo is a drug that looks like the study drug but contains no medication.) The usual chemotherapy in this study is paclitaxel (WP) and carboplatin followed by doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC). Usually, after neoadjuvant therapy and surgery for triple negative breast cancer, no additional treatment is given unless the cancer returns. This study will also look at continuing treatment after surgery with atezolizumab or the placebo. To be better, atezolizumab given with the neoadjuvant therapy should be better at: 1) decreasing the amount of tumor in the breast than the placebo given with the usual chemotherapy and 2) decreasing the chance of the cancer from returning after surgery.

Another purpose of this study is to test the good and bad effects of atezolizumab when added to the usual chemotherapy. Atezolizumab may keep your cancer from growing but it can also cause side effects.

Closed to Enrollment

Study Identifier: NSABP B-58
Study Investigator: Radhika Rachamalla, MD

StudyTitle: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

Study Summary:The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.


Study Identifier: TARGIT-US 
Principal Investigator: Dimitrios Papadopoulos, MD
Study Title: Targeted Intraoperative Radiotherapy United States (TARGIT-US) Registry Trial
Type of Breast Cancer: Early stage invasive breast cancer that is suitable for removal of only the breast tumor (known as breast conservation surgery or lumpectomy)

Study Summary: The purpose of this study is to evaluate the use of targeted intraoperative radiation therapy (IORT), where radiation is given one time during surgery. This is different from the typical treatment of external beam radiation therapy (EBRT), in which patients return periodically to receive radiation therapy after surgery. This study is looking to see if there are any differences between women who receive standard radiation after surgery versus those who receive IORT.


Study Identifier: ACOSOG Z11102
Principal Investigator: Dimitrios Papadopoulos, MD
Study Title:Breast-Conserving Surgery and Radiation Therapy in Patients with Multiple Ipsilateral Breast Cancer
Type of Breast Cancer: Multiple ipsilateral breast cancer (MIBC), which means having more than one tumor in the same breast

Study Summary: The purpose of the Z11102 study is to determine whether removal of only the tumor tissues from the breast (known as breast conservation surgery or lumpectomy) with radiation is as effective as the removal of the entire breast (known as a mastectomy) with radiation, at keeping the cancer from returning.


Study Identifier: NSABP B-42
Principal Investigator: Radhika Rachamalla, MD
Study Title: Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer
Type of Breast Cancer: Breast cancer with a positive estrogen and/or progesterone receptor

Study Summary: The main purpose of the B-42 study is to learn whether or not continuing hormonal therapy with a drug called letrozole for five additional years after already taking five years of hormonal therapy can further reduce the chance of breast cancer from recurring. Letrozole is considered investigational in this trial because it has not yet received approval from the U.S. FDA for use after five years of hormonal therapy.


Study Identifier: NSABP B-43
Principal Investigator: Radhika Rachamalla, MD
Study Title:Radiation Therapy With or Without Trastuzumab for Women with Her2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy
Type of Breast Cancer: Ductal carcinoma in situ (DCIS) early stage breast cancer also known as intraductal or non-invasive breast cancer

Study Summary: The B-43 study is being done to find out if adding a drug called trastuzumab to breast radiation therapy, will be more effective than radiation therapy without trastuzumab in treating DCIS. Radiation therapy is the standard treatment for patients with DCIS. In this study, trastuzumab is considered to be investigational because it has not been approved by the U.S. FDA for use in the treatment of DCIS.


Study Identifier: PACCT-1 (TAILORx)

Principal Investigator: Radhika Rachamalla, MD
Study Title: Hormone Therapy with or without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer
Type of Breast Cancer: Breast cancer with a positive estrogen and/or progesterone receptor with no cancer cells in the lymph nodes, known as negative axillary nodes

Study Summary: The purpose of the PACCT-1 study is to determine whether breast cancer patients would benefit from hormonal therapy with or without chemotherapy, after having surgery. Another objective of this study is to create a tissue and blood specimen bank that includes specimens from all women who participate in this study, and to collect follow-up information regarding the health status of all women who participate in the study. This will hopefully allow researchers to evaluate and develop new tests in the future as they develop.


Study Identifier: CALGB 40601
Principal Investigator: James M. Leonardo, MD
Study Title: Paclitaxel and Trastuzumab with or without Lapatinib in Treating Patients with Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
Type of Breast Cancer: HER2-positive breast cancer

Study Summary: The purpose of the CALGB 40601 study is to see if combining lapatinib and trastuzumab (anti-HER2 drugs) with paclitaxel (chemotherapy drug) before surgery increases tumor shrinkage in the breast. Researchers will study whether there is any cancer left in the breast tissue when the surgeon removes the lump or the breast, and evaluate if there is any difference in the likelihood of there being no cancer left when comparing the breast tissue of the participants who have received lapatinib plus chemotherapy or trastuzumab plus chemotherapy.


Study Identifier: ACOSOG Z1071
Principal Investigator: Radhika Rachamalla, MD
Study Title: Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Type of Breast Cancer: Breast cancer that appears to have spread to the sentinel and axillary lymph nodes known as node positive breast cancer. Sentinel lymph nodes are the first lymph nodes to which cancer cells are most likely to spread from a primary tumor. An axillary node is a lymph node in the armpit region.

Study Summary: The Z1071 study will evaluate the role of sentinel lymph node dissection (SLND) surgery and axillary lymph node dissection (ALND) surgery after chemotherapy. This study will evaluate if SLND is effective in identifying cancer remaining in the lymph nodes after chemotherapy and therefore can be used to determine which patients would benefit from an ALND procedure, and which patients might not need an ALND procedure.


Study Identifier: TARGIT-Int'l
Principal Investigator:  Dimitrios Papadopoulos, MD
Study Title: Comparison of Intra-operative Radiotherapy with Post-operative Radiotherapy for Women with Early Breast Cancer (TARGIT)
Type of Breast Cancer: Early stage invasive breast cancer

Study Summary:The purpose of the TARGIT-Int'l study is to evaluate the use of targeted intraoperative radiation therapy (IORT), where radiation is given one time during surgery, with early stage invasive breast cancer. This study is trying to evaluate whether there is any difference between IORT and the usual course of radiation treatment after surgery (called postoperative radiation therapy) in reducing the risk of the cancer returning in the affected breast and the long-term changes to the breast tissue.