List of Open Breast Cancer Surgical Clinical Trials

List of Open Breast Cancer Surgical Clinical Trials

AFT-25: Comparison of Operative to Monitoring and choice for Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial Principal Investigator: Shelley Hwang MD MPH

There has been a growing recognition of the potential for overtreatment in patients diagnosed with low risk stage 0 breast cancer, or ductal carcinoma in situ (DCIS). COMET is a prospective randomized trial that will assess the risks and benefits associated with active surveillance versus guideline concordant care for patients with low-risk DCIS. The COMET Trial will answer the question of whether management of low-risk DCIS using an active surveillance approach results in equivalent cancer or quality of life outcomes compared to guideline concordant care. Women who are at least 40 years of age at diagnosis who present with a new diagnosis of grade I or II DCIS may be eligible to participate in the study. DCIS must be estrogen receptor positive and/or progesterone receptor positive. Women in the active surveillance group will have regular follow up every 6 months with a mammogram and a study visit. The trial will be open at approximately 100 sites across the United States. Results from this study will help to determine for the first time, whether de-escalation of treatment for low-risk DCIS is a feasible approach, and which women with low risk DCIS might safely avoid surgery and radiation for this disease.


A11104: Effect of Preoperative Breast MRI on Surgical Outcomes, Costs and Quality of Life of Women with Breast Cancer.

Principal Investigator: Isabelle Bedrosian, MD

Breast cancer patients with estrogen and progesterone negative (ER and PR negative) tumors who undergo lumpectomy have higher likelihood of recurring in the same breast compared to patients with ER and PR positive tumors. One reason for this may be that these ER and PR negative tumors are more resistant to the radiation treatment given following lumpectomy. This radiation is given with the goal or eradicating any microscopic areas of cancer that may remain after lumpectomy. In women with ER and PR negative cancers, since such radiation is less effective, better imaging to identify and remove areas of disease in the breast may be important to reducing recurrence rates.

This study is investigating whether using breast MRI to better identify areas of disease in the breast and thus to better tailor surgery, would result in reduction in recurrence rates in women with ER and PR negative tumors who undergo lumpectomy and radiation.


A11202: A Randomized Phase III Trial Evaluating the Role of Axillary Lymph Node Dissection in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy.

Principal Investigator: Judy Boughey, MD

Patients diagnosed with breast cancer that involve the axillary lymph nodes and are treated with chemotherapy prior to surgery are eligible for this trial. This study is designed to evaluate the best method of management of the axillary lymph nodes after completion of chemotherapy in those patients where there is still residual disease in the axillary lymph nodes. All these patients receive radiation therapy to the other lymph node basins (below and above the collar bone). This trial focuses on the management of level I and II axillary lymph nodes. Should these axillary nodes be removed with surgery – axillary lymph node dissection or can surgical resection be limited to SLN surgery to remove the first few nodes and the axilla treated with axillary radiation therapy. Since all patients receive radiation to the other nodal basins, this study provides an opportunity for patients to avoid axillary dissection.


NSABP B-51/RTOG 1304:  A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy.

Principal Investigators: Eleftherios Mamounas, MD, MPH and Julia White, MD

This trial evaluates whether the addition of chest wall and regional nodal radiation therapy (XRT) after mastectomy or breast and regional nodal XRT after breast conserving surgery will significantly reduce the rate of events for invasive breast cancer recurrence-free interval in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy. Eligible patients must have clinically T1-3, N1 breast cancer at the time of diagnosis and must have had pathologic confirmation of axillary nodal involvement at presentation based on either a positive FNA or positive core needle biopsy. Patients must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy unless medically contraindicated.  The B-51/1304 study will enroll 1636 patients over a period of 5 years.


A11106: Alternate approaches for clinical stage II or III Estrogen Receptor positive breast cancer NeoAdjuvant Treatment (ALTERNATE) in postmenopausal women.

Principal Investigator: Cynthia X. Ma, MD, PhD

Postmenopausal women with newly diagnosed estrogen receptor positive breast cancer are potentially eligible for this trial.  Mastectomy (removal of the whole breast) is often needed in these patients if the cancer is large.  To increase the chance of breast conservation, doctors often prescribe anastrozole before surgery to shrink the cancer.   Anastrozole lowers estrogen level and is a standard of care medication for these patients. The goal of this trial is to determine whether fulvestrant, or the combination of fulvestrant and anastrozole, is better than anastrozole to shrink breast cancer before surgery.  Fulvestrant is a drug that degrades estrogen receptor and is currently approved by FDA for use in patients with metastatic breast cancer but not yet for use before surgery.  Another important aspect of this trial is that treatment is individualized based on a test called Ki67, which measures cell growth in cancer cells, during treatment and the PEPI (preoperative endocrine prognostic index) score at surgery, to determine whether chemotherapy is needed. This avoids chemotherapy for patients with cancers that are sensitive to either anastrozole or fulvestrant.


Cryoablation of Low Risk Small Breast Cancer – Ice3 Trial

Principal Investigator: Susan Boolbol, MD

Cryotherapy is the use of liquid nitrogen to freeze cells and cause cell death. Cryoablation is an outpatient procedure and is done in the physician’s office.

The ICE3 trial is currently open nationwide, investigating the use of cryotherapy in early stage breast cancer. In order to participate, you must have a diagnosis of invasive ductal carcinoma, be 65 years old or older, have estrogen and/or progesterone receptors on your tumor, Her-2-neu negative, and the size of the tumor must be 1.5 cm or less. Up to 20 sites in the United States are recruiting patients for this trial. Patients participating in this trial will have an in office cryoablation procedure instead of surgery to treat their breast cancer tumor. The procedure is done in the physician’s office, in about 30-45 minutes, and patients can return to their regular activities, without limitations after the procedure. The procedure is similar to a biopsy. Local anesthesia is injected into the breast, a small cut is made in the breast, and the cryoablation device is placed into the breast with ultrasound guidance. After the tumor is frozen, a small bandage or steristrips will be placed on the cut. There is minimal cosmetic impact from this procedure. There will be a lump where the ice ball is made around the tumor, but this will dissolve over time.

Patients will be followed for 5 years. The primary endpoints of the trial are tumor recurrence and complete tumor ablation. They will have standard breast cancer treatment, such as radiation as indicated by their surgeon.


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