Study on Using Carboplatin and Docetaxel Before Surgery for Triple Negative Breast Cancer
Sponsor: Mothaffar Rimawi
ClinicalTrials ID:NCT02547987
This clinical trial is testing whether a combination of two chemotherapy drugs, docetaxel and carboplatin, given before surgery, can effectively treat patients with triple negative breast cancer.
Patient Parameters
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Program Overview
The aim of this study is to find out if using the chemotherapy drugs docetaxel and carboplatin before surgery can help eliminate all signs of invasive breast cancer in patients with triple negative breast cancer. Researchers want to see if this treatment can increase the number of patients who have no remaining cancer in their breast and nearby lymph nodes after treatment, compared to past results.
Description
The main goal of this study is to determine if giving the chemotherapy drugs docetaxel and carboplatin before surgery can increase the chances of completely removing all invasive breast cancer in patients with triple negative breast cancer. This is known as achieving a pathologic complete response (pCR), which means no cancer is found in the breast or nearby lymph nodes after treatment.
Participants in this study will receive the combination of docetaxel and carboplatin before undergoing surgery. The study will compare the results to historical data to see if this approach improves outcomes for patients with this type of breast cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have been diagnosed with invasive breast cancer.
- Breast cancer must be negative for estrogen receptors (ER) and HER-2, but may have low levels of progesterone receptors (PgR).
- The primary breast tumor must be at least 2 cm in size, as measured by a doctor or imaging tests. If there are multiple tumors, each must be ER-negative and HER2-negative, and one must be chosen as the main tumor to track.
- Patients with inflammatory breast cancer can join if they have a breast mass of at least 2 cm that can be seen on a mammogram or ultrasound.
- Must have normal blood and organ function, including:
- White blood cell count over 3,000/mcL
- Neutrophil count over 1,200/mcL
- Platelet count over 100,000/mcL
- Bilirubin levels within 1.5 times the normal limit
- Liver enzymes (AST/ALT) within 2.5 times the normal limit
- Creatinine levels within 1.5 times the normal limit
- Women who can become pregnant must use effective birth control and have a negative pregnancy test before starting treatment.
- Must be able to understand and agree to the study requirements, including signing a consent form and undergoing study biopsies.
Exclusion Criteria
- Have received any chemotherapy for breast cancer in the past 5 years.
- Have had another cancer in the past 5 years, except for certain skin cancers or cervical cancer that were treated and cured.
- Have cancer in both breasts, unless the cancer in the other breast is non-invasive.
- Have inflammatory breast cancer.
- Have stage IV breast cancer.
- Are currently taking any experimental drugs.
- Have allergies to similar drugs as docetaxel or carboplatin.
- Are positive for HIV, hepatitis B, or hepatitis C.
- Have uncontrolled health issues, such as ongoing infections, heart problems, or mental health conditions that would interfere with the study.
- Are pregnant or breastfeeding.
- Are not considered a suitable candidate for the study by the lead researcher.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| TriHealth Hatton Research | 45242 | Cincinnati | Ohio |
| Lester & Sue Smith Breast Center at Baylor College of Medicine | 77030 | Houston | Texas |
| Harris Health System Smith Clinic | 77054 | Houston | Texas |
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