RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and carboplatin in treating women who have metastatic breast cancer.
OBJECTIVES: I. Determine the anti-tumor activity of docetaxel and carboplatin in women with metastatic adenocarcinoma of the breast. II. Determine the objective response rate, time to progression, and survival in patients treated with this regimen. III. Determine the toxic effects of this regimen in these patients. IV. Assess the common functional polymorphisms in genes involved in chemotherapeutic response to improve prediction of clinical outcomes and provide insight into the potential for genotype-specific drug dosage.
OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve stable disease (SD), partial response (PR), or complete response (CR) may receive 4 additional courses past SD, PR, or CR. Patients are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A maximum of 55 patients will be accrued for this study within 11 months.
Primary Purpose: Treatment
Breast Cancer
carboplatin, docetaxel
CCOP - Scottsdale Oncology Program
Scottsdale
Arizona
United States
85259-5404
Completed
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:32-0400
Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from div...
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as t...
To investigate the clinical efficacy of the following drug combinations: - Docetaxel and Carboplatin with trastuzumab - Docetaxel and Carboplatin, lapatinib - Docetaxel a...
Triple Negative Breast Cancer Trial
The purpose of this study is to determine whether there is greater activity for carboplatin than a taxane standard of care (docetaxel) in women with ER-, PR- and HER2- breast cancer. The t...
Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
The purpose of this study is to determine whether the combination of docetaxel and carboplatin is an effective treatment for patients with triple negative breast cancer.
Docetaxel is standard first-line chemotherapy for patients with metastatic castration-resistant prostate carcinoma (mCRPC). Docetaxel re-challenge has never been tested in a prospective randomised con...
Although several randomised trials in patients with triple-negative breast cancer have shown that the addition of carboplatin, with or without poly(ADP-ribose) polymerase (PARP) inhibitors, to neoadju...
The approval of injectable generic drugs does not require bioequivalence testing. However, although generic products contain the same level of the active compound, the levels and types of additives pr...
Pathological complete response (pCR) is associated with improved prognosis in triple-negative breast cancer (TNBC). The optimal chemotherapy regimen is unclear. Weekly nab-paclitaxel vs conventional p...
The purposes of this study were to investigate the incidence of lymphedema in patients with breast cancer during and after adjuvant treatment with docetaxel, doxorubicin, and cyclophosphamide (TAC), t...
Breast Cancer Lymphedema
Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Carcinoma, Lobular
A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)
Capecitabine
A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.
Mucin-1
Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.