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Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00321633
Recruitment Status : Completed
First Posted : May 4, 2006
Last Update Posted : August 26, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 dividing. It is not yet known whether carboplatin is more effective than docetaxel in treating patients with metastatic genetic breast cancer.

PURPOSE: This randomized phase II trial is studying carboplatin to see how well it works compared to docetaxel in treating women with metastatic genetic breast cancer.


Condition or disease Intervention/treatment Phase
brca1 Mutation Carrier brca2 Mutation Carrier Breast Cancer Hereditary Breast/Ovarian Cancer (brca1, brca2) Drug: carboplatin Drug: docetaxel Phase 2

Detailed Description:

OBJECTIVES:

Primary

  • Compare the safety and effectiveness of carboplatin vs docetaxel in women with metastatic breast cancer and the BRCA1 or BRCA2 gene mutation.

Secondary

  • Compare time to disease progression in patients treated with these regimens.
  • Compare progression-free survival of patients treated with carboplatin vs docetaxel.

OUTLINE: This is a randomized, open-label, multicenter, pilot study. Patients are stratified according to gene mutation (BRCA1 vs BRCA2), prior adjuvant taxane chemotherapy (yes vs no), liver or lung metastasis affecting the parenchyma (yes vs no), Jewish ancestry by parent or grandparent (yes vs no), and first-line treatment vs second-line treatment. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive carboplatin IV over 1 hour on day 1.
  • Arm 2: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 3 or 6 courses of treatment may crossover to the alternative treatment arm. If progression is present after 3 courses in the crossover arm, patients may receive further treatment at the discretion of their oncologist. Patients responding to and tolerating treatment well, may be given 2 further courses in accordance with local center policy, although this is not encouraged.

Patients with HER2-positive disease may receive trastuzumab (Herceptin®) IV once every 7 or 21 days.

After completion of study treatment, patients are followed periodically for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
Study Start Date : September 2005
Actual Primary Completion Date : September 2009





Primary Outcome Measures :
  1. Response and toxicity

Secondary Outcome Measures :
  1. Time to progression


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • BRCA1 or BRCA2 mutation carrier
    • Metastatic disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Stable, treated brain metastases allowed provided other sites of measurable disease are present
  • Patients with bone metastases who are currently receiving bisphosphonates for palliation are eligible provided other sites of measurable disease are present
  • Patients who have not received anthracycline-based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first-line metastatic treatment and enter the trial at confirmed progression (second-line)
  • No bone-limited disease
  • No disease suitable for endocrine therapy alone
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • Sex: female
  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • AST and/or ALT ≤ 5 times upper limit of normal (ULN) (≤ 3 if alkaline phosphatase > 5 times ULN)
  • Glomerular filtration rate ≥ 30 mL/min
  • Normal urea and creatinine
  • Normal hematological and biochemical studies
  • Normal bilirubin
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • Negative pregnancy test
  • No known allergy to platinum compounds or mannitol
  • No known sensitivity to taxanes
  • No other malignancy within the past 10 years except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
  • No sensory or motor neuropathy > grade 1
  • No other serious uncontrolled medical conditions or concurrent medical illness that would preclude study compliance
  • No contraindication to chemotherapy

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 12 months since prior taxane therapy
  • No prior chemotherapy with a platinum drug, unless treatment was for a non-breast cancer-related disease more than 10 years ago

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321633


Locations
Show Show 25 study locations
Sponsors and Collaborators
University College London Hospitals
Investigators
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Study Chair: Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP Guy's Hospital

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ClinicalTrials.gov Identifier: NCT00321633    
Other Study ID Numbers: CDR0000467994
CRUK-BRCA-TRIAL
EUDRACT-2004-001496-20
EU-20603
ISRCTN43372330
BBC-CRUK-BRCA-TRIAL
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: July 2009
Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
hereditary breast/ovarian cancer (BRCA1, BRCA2)
BRCA1 mutation carrier
BRCA2 mutation carrier
Additional relevant MeSH terms:
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Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carboplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action