Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University College London Hospitals
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00321633
First received: May 2, 2006
Last updated: January 1, 2010
Last verified: July 2009
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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 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321633
Locations
| Australia, Victoria | |
| Royal Melbourne Hospital | Recruiting |
| Parkville, Victoria, Australia, 3050 | |
| Contact: Geoffrey Lindeman, MD 61-3-9342-7151 | |
| Israel | |
| Soroka University Medical Center | Recruiting |
| Beer-Sheva, Israel, 84101 | |
| Contact: Contact Person 972-8-640-0225 | |
| Naharia Hospital | Recruiting |
| Naharia, Israel | |
| Contact: Contact Person 972-4910-3482 | |
| Chaim Sheba Medical Center | Recruiting |
| Tel Hashomer, Israel, 52621 | |
| Contact: Contact Person 972-3-530-2988 | |
| Portugal | |
| Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA | Recruiting |
| Lisbon, Portugal, 1099-023 Codex | |
| Contact: Contact Person 351-21-722-9800 | |
| Spain | |
| Vall d'Hebron University Hospital | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: Contact Person 34-93-274-6085 | |
| Sweden | |
| Lund University Hospital | Recruiting |
| Lund, Sweden, SE-22185 | |
| Contact: Contact Person 46-46-178-526 | |
| United Kingdom | |
| Addenbrooke's Hospital | Recruiting |
| Cambridge, England, United Kingdom, CB2 2QQ | |
| Contact: Helena Earl, MBBS, PhD, FRCP 44-1223-336-800 | |
| Royal Devon and Exeter Hospital | Recruiting |
| Exeter, England, United Kingdom, EX2 5DW | |
| Contact: Anne Hong, MD 44-139-240-2118 anne.hong@rdeft.nhs.uk | |
| UCL Cancer Institute | Recruiting |
| Hampstead, London, England, United Kingdom, NW3 2QG | |
| Contact: Alison L. Jones, MD 44-171-830-2184 alison.jones@royalfree.nhs.uk | |
| Cookridge Hospital | Recruiting |
| Leeds, England, United Kingdom, LS16 6QB | |
| Contact: Julian Adlard, MD 44-113-392-4224 | |
| Leeds Cancer Centre at St. James's University Hospital | Recruiting |
| Leeds, England, United Kingdom, LS9 7TF | |
| Contact: Julian Adlard, MD 44-113-392-4224 | |
| Guy's Hospital | Recruiting |
| London, England, United Kingdom, SE1 9RT | |
| Contact: Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP 44-20-7188-4237 andrew.tutt@icr.ac.uk | |
| Royal Marsden - Surrey | Recruiting |
| London, England, United Kingdom, SW3 6JJ | |
| Contact: Ian E. Smith, MD 44-20-7808-2751 ian.smith@rmh.nhs.uk | |
| Christie Hospital | Recruiting |
| Manchester, England, United Kingdom, M20 4BX | |
| Contact: Andrew M. Wardley, MD 44-161-446-3746 andrew.wardley@christie-tr.nwest.nhs.uk | |
| Clatterbridge Centre for Oncology | Recruiting |
| Merseyside, England, United Kingdom, CH63 4JY | |
| Contact: Susan M. O, MD 44-151-334-1155 sue.oreilly@ccotrust.nhs.uk | |
| James Paget Hospital | Recruiting |
| Norfolk, England, United Kingdom, NR31 6LA | |
| Contact: Adrian Harnett, MD 44-1493-453-705 | |
| Mount Vernon Cancer Centre at Mount Vernon Hospital | Recruiting |
| Northwood, England, United Kingdom, HA6 2RN | |
| Contact: David Miles, MD 44-1923-844-723 davidmiles@nhs.net | |
| Norfolk and Norwich University Hospital | Recruiting |
| Norwich, England, United Kingdom, NR4 7UY | |
| Contact: Adrian Harnett, MD 44-1603-286-561 | |
| Dorset Cancer Centre | Recruiting |
| Poole Dorset, England, United Kingdom, BH15 2JB | |
| Contact: Susan Dean, MD 44-1202-442-491 | |
| Portsmouth Oncology Centre at Saint Mary's Hospital | Recruiting |
| Portsmouth Hants, England, United Kingdom, PO3 6AD | |
| Contact: Caroline Archer, MD 44-23-9228-6000 ext. 2363 | |
| Southampton General Hospital | Recruiting |
| Southampton, England, United Kingdom, SO16 6YD | |
| Contact: Peter Simmonds 44-23-8079-3627 | |
| Torbay Hospital | Recruiting |
| Torquay, England, United Kingdom, TQ2 7AA | |
| Contact: Contact Person 44-1803-655-385 | |
| Edinburgh Cancer Centre at Western General Hospital | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Contact: Ian H. Kunkler, MD 44-131-537-2214 i.kunkler@ed.ac.uk | |
| Velindre Cancer Center at Velindre Hospital | Recruiting |
| Cardiff, Wales, United Kingdom, CF14 2TL | |
| Contact: Peter J. Barrett Lee, MD 44-2920-615-888 | |
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: | January 1, 2010 |
| 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 May 16, 2013