NRG-BR003

NRG-BR003: A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with  or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Purpose:

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. The purpose of this study is to compare the good and bad effects of the chemotherapy drug, carboplatin, given with the usual chemotherapy drugs after surgery, compared to the usual chemotherapy drugs given without carboplatin.  The addition of carboplatin to the usual chemotherapy could prevent your cancer from returning, but it could also cause side effects.  This study will allow the researchers to know whether giving carboplatin with the usual chemotherapy is better, the same, or worse than giving the usual chemotherapy.  If giving carboplatin with the usual chemotherapy drugs is better, there should be a higher chance that your breast cancer will not return.  Carboplatin is FDA-approved for the treatment of cancer and is used for the treatment of breast cancer that has spread, but it has not yet been proven useful in earlier stages of breast cancer. There will be about 990 people taking part in this study.

You will be "randomized" into one of two study groups in part one of the study. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups.  Neither you nor your doctor can choose the group you will be in.  You will have an equal chance of being placed in any group.

Group 1
Patients will receive the usual chemotherapy drugs used for this type of cancer: doxorubicin and cyclophosphamide, followed by paclitaxel. (AC-->WP).  

Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 weeks (called a cycle) for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel IV over 60 minutes on day 1. Treatment repeats weekly for 12 courses in the absence of disease progression or unacceptable toxicity.

Group 2
Patients will receive the usual chemotherapy drugs used for this type of cancer: doxorubicin and cyclophosphamide, followed by paclitaxel plus the chemotherapy drug called carboplatin. (AC-->WP + carboplatin).

Patients receive doxorubicin hydrochloride and cyclophosphamide as in Arm I. Patients then receive paclitaxel IV over 60 minutes on days 1, 8, and 15 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 3 weeks (called a cycle) for 4 courses in the absence of disease progression or unacceptable toxicity.

Follow Up:

After completion of study treatment, patients are followed for 10 years.

Partial Eligibility Criteria:

  • Pathological proven single-sided invasive adenocarcinoma of the breast 
    • primary tumor must  not involve skin, muscle or ulcerate the skin
    • lymph nodes must be  unaffected or only positive on the same side of the body as the primary tumor and not above the clavicle bone
    • if lymph nodes are negative, tumor must be > 3.0 cm in size
  • The tumor must be estrogen receptor (ER)-and progesterone receptor (PgR)-negative, human epidermal growth factor receptor 2 (HER2)-negative 
  • Must have undergone either a mastectomy within 60 days (total, skin-sparing, or nipple-sparing) or lumpectomy. For patients who undergo lumpectomy, the margins of the resected specimen must be free of invasive tumor and ductal carcinoma in situ (DCIS).
  • No previous  history of breast cancer
  • No history of other cancers within 5 years 
  • No use of any investigational product within 4 weeks prior to randomization
  • Must not have other serious uncontrolled illness including, but not limited to, active such as cardiac disease, hypertension, peripheral motor or sensory neuropathy, hepatitis B or hepatitis C, acquired immune deficiency syndrome (AIDS), chronic infection or intrinsic lung disease
  • Women must not be pregnant or breast-feeding

For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515

RTOG 3510

RTOG 3510 Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial

Purpose:

This randomized clinical trial studies patients with locally advanced breast cancer who receive radiation therapy.  The patient will be randomized to either proton or photon radiation therapy and followed over time for cardiovascular side effects, health-related quality of life (HRQOL), and outcome of cancer treatment.

Both PHOTON THERAPY and PROTON THERAPY are FDA-approved radiation treatments and are on the cutting-edge of cancer therapy. Both of these treatments are routinely used at our center for your type of breast cancer. PHOTON THERAPY and PROTON THERAPY deliver similar radiation doses to your chest wall or breast tissue and the immediate surrounding lymph node areas. Because there may be small amounts of radiation to parts of the heart during radiation treatment, both PHOTON THERAPY and PROTON THERAPY may increase your chances of having heart problems in the future.

PROTON THERAPY reduces the amount of heart exposed to radiation. So, it has the potential to reduce heart problems compared to PHOTON THERAPY. PROTON THERAPY has not been used as commonly to treat breast cancer, so the risks and benefits of PROTON THERAPY are not as well documented as for PHOTON THERAPY. Proton therapy may also cause more skin reaction than photon therapy. Doctors do not know if one type of radiation is better, about the same, or worse in terms of side effects, cure rates, length of life or quality of life after radiation. That is what we are trying to learn.

No studies in patients with breast cancer have compared overall or breast cancer-specific survival or relapse rates between PHOTON THERAPY and PROTON THERAPY.  Studies in other cancers have shown that PROTON THERAPY results in a cancer control similar to PHOTON THERAPY. Doctors also know that radiation therapy after surgery (either lumpectomy or mastectomy) improves breast cancer-specific and overall survival for women with non-metastatic breast cancer.

Because no one knows which radiation treatment is best, if you decide to take part in this study, you will be randomly assigned to 1 of 2 treatment groups, and then you will begin radiation treatment according to usual medical practice. Randomly assigning you to a group helps makes sure that each group has a similar mix of patients and makes the study better - and is only done when doctors are not sure whether one treatment is better than the other. You have an equal chance of getting into either treatment group, like a coin flip. Both you and your doctor will be told which treatment you will get.

No matter which group patients are in, doctors will work very carefully to reduce the radiation to healthy tissues.

Group 1:
Photon therapy: once a day, 5 days a week, for 5 to 7 weeks

Group 2:
Proton therapy: once a day, 5 days a week, for 5 to 7 weeks

Follow Up:

Both groups will followed for at least 10 years after completing radiation therapy. 

Partial Eligibility Criteria:

  • Patients with non-metastatic breast cancer that are diagnosed with pathologically proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling.
  • Patients with non-metastatic breast cancer are eligible. 
  • Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment.
  • Women must not be pregnant
  • Confirmation that the patient's health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles). If the patient's insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received.
  • Must not have received prior radiotherapy to the intended treatment area
  • Must not have any other systemic disease that would prevent the patient from receiving study treatment or would prevent required follow-up.

For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515

S1418/BR006

S1418/BR006 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.

Brief Summary:

This randomized phase III trial studies how well pembrolizumab works in treating patients with triple-negative breast cancer compared to the current standard of care.  
Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

 

Treatment Arms:

This research study has two study groups.  You will be "randomized" into one of two groups in the study. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups.  Neither you nor your doctor can choose the group you will be in.  You will have an equal chance of being placed in either group.  This is done to make each group as alike as possible.

Arm I (observation) 
Standard of care clinical monitoring intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, every 6 months for 4 years, and then annually for 5 years. 

Arm 2 (MK-3475 pembrolizumab) 
Pembrolizumab IV over 30 minutes on days 1 and 22 repeated every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity

 

Follow-Up:

Observation (Arm 1), follow up visits with physician every 12 weeks for one year then every 6 months (for 4 years), then every 12 months for the next 5 years. 

MK-3475 (pembrolizumab) treatment group (Arm 2) once finished with study treatment, follow-up visits with physician will be 6 weeks (-/+ 1 week) after the last dose of the study drug.  The visits will then be every 6 months (+/- 4 weeks) after the last dose of study drug until five years from the start of treatment, then every 12 months for the next 5 years.  

Partial Eligibility Criteria:

  • Triple-negative, (TNBC) - estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative 
  • Must have had neoadjuvant chemotherapy 
  • Have disease remaining in the breast, must be >= 1 cm in greatest dimension, and/or have positive lymph nodes after surgery 
  • May receive post-operative (adjuvant) chemotherapy for up to 24 weeks of duration 
  • Radiation therapy (RT) to the affected breast or chest wall and regional nodal areas may be initiated, administered, completed or when possible if randomized to the experimental arm receive MK-3475 (pembrolizumab) concurrently with RT

Final eligibility assessment is done by the health care professionals associated with the trial. 

 

For additional information, please contact the Research Nurses:

  • Nona Blauvelt, RN, MSN, AOCN; 610-738-2522
  • Susan Metzger, RN, MSN; 610-738-2515
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