Breast CancerNCT00870168
Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer
A study testing chemotherapy, gene expression analysis and laboratory biomarker analysis in people with Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- chemotherapy, gene expression analysis and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to May 2011
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast
- Metastatic disease
- No inflammatory breast cancer
- Measurable disease according to RECIST criteria
- Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-negative by IHC
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- WHO performance status 0-2
- Life expectancy > 3 months
- ANC > 1.5 x 10^9/L
- Platelet count > 100 x 10^9/L
- Liver transaminases ≤ 3 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Bilirubin ≤ 1.5 times ULN
- Creatinine ≤ 2 times ULN
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No allergy to xylocaine
- No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency
PRIOR CONCURRENT THERAPY:
- No prior first-line treatment for metastatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.
RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.
Secondary
- Assess changes in HER1 and HER2 expression during treatment.
OUTLINE: This is a multicenter study.
Patients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy.
Patients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression.
After completion of study treatment, patients are followed every 6 months for 5 years.
- Conditions
- Breast Cancer
- Being tested
- chemotherapy, gene expression analysis, laboratory biomarker analysis, breast biopsy
- Keywords
- stage IV breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
gene expression analysisGenetic
laboratory biomarker analysisOther
breast biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in hormone receptor expression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJan 2006
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Chollet, MD, PhD, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870168
- Sponsor's protocol ID
- CDR0000626717
- Other IDs
- JEANP-AU-613, INCA-RECF0389, JEANP-RH Meta Sein, PFIZER-JEANP-AU-613
- Status last verified
- Jul 2009
- First submitted
- 26 Mar 2009
- Last updated
- 16 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.
- ClinicalTrials.gov ID
- NCT00870168
- Acronym / sponsor ID
- CDR0000626717
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- May 2011 (actual)
- First posted
- 27 Mar 2009 (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: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.
Detailed description
OBJECTIVES:
Primary
- Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.
Secondary
- Assess changes in HER1 and HER2 expression during treatment.
OUTLINE: This is a multicenter study.
Patients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy.
Patients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression.
After completion of study treatment, patients are followed every 6 months for 5 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| chemotherapy | Drug | – |
| gene expression analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| breast biopsy | Procedure or surgery | – |
Primary outcome
Changes in hormone receptor expression
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 16 May 2011.
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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.
Philippe Chollet, MD, PhD
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chemotherapy, gene expression analysis and laboratory biomarker analysis in people with Breast Cancer, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
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?
Changes in hormone receptor expression. 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 16 May 2011.