Study on Chemotherapy and Surgery for Treating Triple Negative Stage II-III Breast Cancer
Sponsor: Rutgers, The State University of New Jersey
ClinicalTrials ID:NCT02315196
This clinical trial is testing a combination of chemotherapy drugs followed by surgery and additional chemotherapy to see how well it works in treating patients with stage II-III triple negative breast cancer.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how well a combination of chemotherapy drugs, including pegylated liposomal doxorubicin hydrochloride and carboplatin, followed by surgery and paclitaxel, works in treating patients with stage II-III breast cancer that is triple negative. Triple negative breast cancer does not have estrogen receptors, progesterone receptors, or large amounts of HER2 protein. The chemotherapy drugs work by stopping the growth of cancer cells in different ways. Giving these drugs before surgery may shrink the tumor, making it easier to remove. This approach may be an effective treatment for this type of breast cancer.
Description
The main goal of this study is to find out how many patients achieve a complete response to the treatment, meaning no signs of cancer are found after treatment with liposomal doxorubicin and carboplatin. The study also aims to determine how long patients remain free of cancer and their overall survival after receiving the treatment, which includes chemotherapy before surgery and paclitaxel after surgery.
Patients will first receive chemotherapy with pegylated liposomal doxorubicin and carboplatin through an IV every 28 days for four cycles, as long as the cancer does not progress or cause severe side effects. After this, patients will undergo surgery to remove the tumor. Following surgery, patients will receive paclitaxel through an IV once a week for 12 weeks, again as long as the cancer does not progress or cause severe side effects.
If there is a shortage of pegylated liposomal doxorubicin, patients may receive a different drug, epirubicin, instead. After completing the study treatment, patients will have follow-up visits every six months for up to 20 years to monitor their health and any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Women with stage II-III breast cancer that is triple negative (does not have estrogen, progesterone, or HER2 receptors).
- Tumor size must be at least 1.0 cm if lymph nodes are not affected.
- Negative pregnancy test for women who can have children.
- Must use effective birth control during treatment and for three months after.
- Good overall health with a performance status score of less than 2.
- Life expectancy of at least 52 weeks, excluding the cancer diagnosis.
- Adequate blood cell counts and organ function, including:
- Neutrophil count of at least 1,500 cells/mm³.
- Platelet count of at least 100,000 cells/mm³.
- Hemoglobin level above 9.0 g/dL.
- Creatinine level below 2.5 mg/dL.
- Liver function tests within specified limits.
- Normal heart function as shown by specific tests.
- No evidence of cancer spread to other parts of the body.
- Must be able to undergo surgery to remove the breast cancer.
- Must provide tumor samples from biopsy and surgery for research purposes.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Have another primary cancer, except for certain non-threatening types.
- Evidence of cancer spread to other parts of the body.
- Diagnosis of inflammatory breast cancer.
- Allergic reactions to any of the study drugs.
- Serious health conditions that could affect safety or ability to complete the study.
- Recent heart problems or severe heart disease.
- Previous treatment with certain chemotherapy drugs.
- Active hepatitis B or C with abnormal liver tests.
- Significant vascular disease or bleeding disorders.
- Severe lung disease causing breathing difficulties.
- History of organ transplant or conditions requiring long-term immunosuppression.
- Severe nerve disorders.
- Conditions that prevent the use of corticosteroids.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | 08903 | New Brunswick | New Jersey |
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