brca1 Mutation CarrierPhase 2NCT00321633
Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
A Phase 2 study testing carboplatin and docetaxel in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by University College London Hospitals at 25 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
- What is being tested?
- carboplatin and docetaxel
- How many people
- 148 participants
- Where
- 25 sitesin 6 countries
- Study dates
- Sep 2005to Sep 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
25 sites in 6 countries.
25 sites in 6 countries
United Kingdom18 sites
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Royal Devon and Exeter Hospital
Exeter, England, EX2 5DW
UCL Cancer Institute
Hampstead, London, England, NW3 2QG
Cookridge Hospital
Leeds, England, LS16 6QB
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Guy's Hospital
London, England, SE1 9RT
Royal Marsden - Surrey
London, England, SW3 6JJ
Christie Hospital
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
James Paget Hospital
Norfolk, England, NR31 6LA
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Norfolk and Norwich University Hospital
Norwich, England, NR4 7UY
Dorset Cancer Centre
Poole Dorset, England, BH15 2JB
Portsmouth Oncology Centre at Saint Mary's Hospital
Portsmouth Hants, England, PO3 6AD
Southampton General Hospital
Southampton, England, SO16 6YD
Torbay Hospital
Torquay, England, TQ2 7AA
Israel3 sites
Soroka University Medical Center
Beersheba, 84101
Naharia Hospital
Nahariya
Chaim Sheba Medical Center
Tel HaShomer, 52621
Portugal1 site
Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA
Lisbon, 1099-023 Codex
About this study
Official title: A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
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.
Read the 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.
- Conditions
- brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
- Being tested
- carboplatin, docetaxel
- Keywords
- stage IV breast cancer, recurrent breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2), BRCA1 mutation carrier, BRCA2 mutation carrier
- Medical subject headings
- Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
docetaxelDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response and toxicity
Secondary outcomes (1)
Time to progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startSep 2005
- Primary completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for brca1 Mutation CarrierStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP, Study chair, Guy's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321633
- Sponsor's protocol ID
- CDR0000467994
- Other IDs
- CRUK-BRCA-TRIAL, EUDRACT-2004-001496-20, EU-20603, ISRCTN43372330, BBC-CRUK-BRCA-TRIAL
- Status last verified
- Jul 2009
- First submitted
- 2 May 2006
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]
- ClinicalTrials.gov ID
- NCT00321633
- Acronym / sponsor ID
- CDR0000467994
- Conditions
- brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2)
- Keywords
- stage IV breast cancer, recurrent breast cancer, hereditary breast/ovarian cancer (BRCA1, BRCA2), BRCA1 mutation carrier, BRCA2 mutation carrier
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Sep 2009 (actual)
- First posted
- 4 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| docetaxel | Drug | – |
Primary outcome
Response and toxicity
1 secondary outcome
Time to progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP study chair
Guy's Hospital
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin and docetaxel in people with brca1 Mutation Carrier and brca2 Mutation Carrier, run by University College London Hospitals at 25 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United Kingdom, Israel, Australia, Portugal, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response and toxicity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2013.