Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00321633
First received: May 2, 2006
Last updated: August 23, 2013
Last verified: July 2009
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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]

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response and toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 148
Study Start Date: September 2005
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321633

Locations
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Israel
Soroka University Medical Center
Beer-Sheva, Israel, 84101
Naharia Hospital
Naharia, Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Portugal
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
Lisbon, Portugal, 1099-023 Codex
Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Sweden
Lund University Hospital
Lund, Sweden, SE-22185
United Kingdom
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
UCL Cancer Institute
Hampstead, London, England, United Kingdom, NW3 2QG
Cookridge Hospital
Leeds, England, United Kingdom, LS16 6QB
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Guy's Hospital
London, England, United Kingdom, SE1 9RT
Royal Marsden - Surrey
London, England, United Kingdom, SW3 6JJ
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, United Kingdom, CH63 4JY
James Paget Hospital
Norfolk, England, United Kingdom, NR31 6LA
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, United Kingdom, HA6 2RN
Norfolk and Norwich University Hospital
Norwich, England, United Kingdom, NR4 7UY
Dorset Cancer Centre
Poole Dorset, England, United Kingdom, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, United Kingdom, PO3 6AD
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Torbay Hospital
Torquay, England, United Kingdom, TQ2 7AA
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, United Kingdom, CF14 2TL
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Chair: Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP Guy's Hospital
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00321633     History of Changes
Other Study ID Numbers: CDR0000467994, CRUK-BRCA-TRIAL, EUDRACT-2004-001496-20, EU-20603, ISRCTN43372330, BBC-CRUK-BRCA-TRIAL
Study First Received: May 2, 2006
Last Updated: August 23, 2013
Health Authority: Unspecified

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:
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
Docetaxel
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014