Clinical Trials for Breast

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Alliance A221505

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction

Patients are being asked to take part in this study because they have been diagnosed with stage 2 or stage 3 breast cancer and the doctor has recommended that they receive radiation therapy after the mastectomy to prevent the breast cancer from coming back. Radiation uses particles of energy to kill any remaining cancer cells where the breast was removed or in the lymph nodes. Radiation after mastectomy has been shown to reduce the number of patients whose breast cancer returns. Women with cancer in their lymph nodes after mastectomy have been shown to live longer when they receive radiation therapy. The purpose of this study is to determine whether a short-course radiation therapy option (3 to 4 weeks) after mastectomy is as safe and effective in the setting of breast reconstruction as the usual 5 to 6 week treatment course. Short-course radiation therapy is also called hypofractionated radiation. This study will also examine whether a shorter course of radiation therapy will lower treatment costs and improve patient satisfaction.
This study has two study groups:

• Group 1 will get the usual 5 to 6 weeks radiation therapy used for this type of cancer.
• Group 2 will get a shortened course with 3 to 4 weeks radiation therapy for this type of cancer.

Radiation in the two treatment groups will be slightly different, as a smaller total radiation dose is necessary when the radiation is given in a shorter period of time. However the effective dose of radiation on the cancer and the body, is thought to be about the same in both treatment groups.

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Principle Investigator: James Lee. M.D.


A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple-Negative Breast Cancer following Neoadjuvant Chemotherapy

Patients are being asked to take part in this study because they:
• Have a breast cancer that does not have the estrogen, progesterone or HER2 receptor, and is called triple-
negative breast cancer
• Have completed chemotherapy prior to surgery
• Had = 1 cm worth of cancer in the breast at the time of surgery

The main purpose of this study is to compare getting more treatment with capecitabine (i.e. one of the usual approaches), to any good and bad effects of getting more treatment with a platinum-based chemotherapy (cisplatin or carboplatin), after surgery.
Platinum agents (cisplatin or carboplatin) are already FDA-approved to be used in patients with stage IV breast cancers, but are usually not used in patients with early forms of breast cancer. Getting a platinum-based chemotherapy after surgery could prevent the cancer from returning (metastatic recurrence), but it could also cause side effects.
Because recent studies have shown that capecitabine chemotherapy is a better treatment than receiving no other treatment, a new study group has been added to replace the current no other treatment group. This study will allow the researchers to know whether this different approach is better, the same, or worse than using capecitabine chemotherapy.

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Principle Investigator: James Lee, M.D.



Patients are being asked to take part in this study because they were diagnosed with breast cancer, received treatment for breast cancer and the cancer returned or returned in another location in the body (metastasis) after treatment in the past or right now.
Cancer progression occurs when a series of mutations within the genes of the cancer cells causes these cancer cells to be more likely to grow and survive. Medical Diagnostic Laboratories, LLC has created a test that identifies mutations and measures the effect of these mutations in the cells and on their response to drugs used for breast cancer treatment. The information obtained from these tests will potentially be used as an additional guideline for choosing optimal treatment for breast cancer patients.

Principle Investigator: Priya Gor, M.D.


A Study On The Use Of Left Over Tumor Blocks For A Research Study On Biomarker Discovery

This research study is a retrospective and anonymized study on breast tumors for identification of markers predictive of risk of recurrence. This is a population cancer study to understand the basic biology of tumors in greater details, which is contributed by different kinds of tumor cells present in a tumor. Since this is a retrospective study all the patients from whom the biopsies/tumor samples are taken have completed treatment, thus no further treatment/investigation will be advised to the individual patients.
The important clinical data of the individual patient will be matched with the results of the biological study. The collective data from all the individuals will be analyzed to find significant, positive correlation if any.
The outcome of this study would be helpful for predicting aggressiveness of cancers for better therapy planning for future patients.

Principle Investigator: Ashok Bapat, M.D.

SWOG S1418

A Randomized Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with = 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Patients are being asked to take part in this study because they have "triple-negative" breast cancer. This means that their type of breast cancer doesn't have receptors for estrogen, progesterone, or the protein HER2, that are found in some other types of breast cancer. Additionally, they have already had preoperative chemotherapy (also called "neoadjuvant" chemotherapy) and the breast cancer has at least partly survived that treatment. Patients in this situation, who are not in a study, usually do not receive any more treatment but some doctors may recommend further chemotherapy. The doctors may also recommend postoperative radiotherapy as part of the usual treatment for this cancer. The purpose of this study is to compare the usual approach (i.e. no more treatment or additional post-operative chemotherapy), to any effects, good and/or bad, of the experimental drug MK-3475 (also called pembrolizumab) after surgery. This study will allow the researchers to know whether treatment with MK-3475 (pembrolizumab) is better, the same, or worse than the usual approach. There will be about 1,000 people taking part in this study. This study has two study groups (also called study "arms"). Patients in Arm 1, will get the usual approach used for this type of cancer: either observation or more chemotherapy as determined by the physician. The doctors may recommend postoperative radiotherapy as part of usual treatment. Patients will have visits with their physician every 12 weeks for one year. Patients in Arm 2 will receive the usual care the physician recommends [which may include up to 6 months of adjuvant chemotherapy after surgery before starting MK-3475 (pembrolizumab) and/or 2) postoperative radiotherapy together with MK-3475 (pembrolizumab)] and will also receive MK-3475 (pembrolizumab) by intravenous infusion over a 30 minute period. This infusion will be in the outpatient setting. Patients will receive MK-3475 (pembrolizumab) infusions every three weeks for one year and will be seen by their physician every 6 weeks during treatment.

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Principle Investigator: James Lee, M.D.


Contacts for Participation in Clinical Trials:

Virtua Samson Cancer Center
Theresa Carducci, MSN, RN, BA, CCRP
Protocol Coordinator, Cancer Registry & Research
(856) 206-4721

Karen Goldsmith, BSN, RN
Protocol Coordinator
(856) 247-7395

Maria Jenkins, CCRP
Clinical Research Coordinator
(856) 247-7396