Breast CancerSPAMNCT00911911
Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant Chemotherapy
A study testing Blood sampling, BIOPSY and SURGERY in people with Breast Cancer, run by Centre Oscar Lambret at 5 sites in France.
Trial summary
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy. 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?
- Blood sampling, BIOPSY and SURGERY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesFrance
- Study dates
- 22 Feb 2007to 16 Jan 2012
- 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
Who may be able to join
- Women aged more than 18 years
- Histologically proven breast carcinoma
- Neo-adjuvant chemotherapy with anthracyclines and/or taxanes
- No prior chemotherapy
- Written informed consent
Who cannot join
- Metastatic disease
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Intercommunal Hospital
Annemasse, 74 107
Centre Oscar Lambret
Lille, 59020
Hopital Saint Vincent
Lille, 59020
Centre Henri Becquerel
Rouen, 76038
Geroges PIANTA Hospital
Thonon-les-Bains, 74 203
About this study
Official title: Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.
- Conditions
- Breast Cancer
- Being tested
- Blood sampling, BIOPSY, SURGERY
- Keywords
- Breast cancer, Neo-adjuvant chemotherapy, Proteomic, Histological response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Taken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy
BIOPSYProcedure or surgery
Biopsy at the moment of inclusion, before neoadjuvant chemotherapy
SURGERYProcedure or surgery
Surgery after neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| FEC 100 + TAXOTERE | Experimental | FEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE
TAXOTERE 100 mg/m²/cycle
1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100 Receives: Procedure: Blood sampling; Procedure: BIOPSY; Procedure: SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
Measured: 6 months
Secondary outcomes (3)
Correlation with node invasion
Measured: 6 months
Correlation with basal, luminal phenotypes, HER2 status or hormonal status
Measured: 6 months
Correlation with the response measured by ultrasound after chemotherapy
Measured: After 3 and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study start22 Feb 2007
- Primary completionJan 2009
- Study completion16 Jan 2012
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BONNETERRE Jacques, MD, PhD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911911
- Sponsor's protocol ID
- SPAM-0610
- Other IDs
- 2006-A00295-46
- Acronym
- SPAM
- Status last verified
- Sep 2026
- First submitted
- 22 May 2009
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Proteomic Signature in Breast Cancer Correlated With Tumor Response in Patients Necessitating a Neo-adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT00911911
- Acronym / sponsor ID
- SPAM / SPAM-0610
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Neo-adjuvant chemotherapy, Proteomic, Histological response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- 22 Feb 2007 (actual)
- Primary completion
- Jan 2009 (actual)
- Study completion
- 16 Jan 2012 (actual)
- First posted
- 3 Jun 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.
The scope of the trial is to identify proteomic signatures correlated with tumor response to neo-adjuvant chemotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FEC 100 + TAXOTERE | Experimental | Procedure: Blood sampling, Procedure: BIOPSY, Procedure: SURGERYFEC 100 = Fluoro-uracile + Epirubicin + Cyclophosphamide Fluoro-uracile : 500 mg/m²/cycle Epirubicin : 100 mg/m²/cycle Cyclophosphamide : 500 mg/m²/cyle 1 cycle = 21 days. For a total of 6 cycles or 3 cycles followed by 3 cycles of TAXOTERE TAXOTERE 100 mg/m²/cycle 1 cycle = 21 days. For a total of 3 cycles following 3 FEC 100 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged more than 18 years
- Histologically proven breast carcinoma
- Neo-adjuvant chemotherapy with anthracyclines and/or taxanes
- No prior chemotherapy
- Written informed consent
Key exclusion criteria (1 listed)
- Metastatic disease
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 |
|---|---|---|
| Blood samplingTaken at different times : inclusion, at the cycle 4 and at the cycle 6 during the neoadjuvant chemotherapy | Procedure or surgery | FEC 100 + TAXOTERE |
| BIOPSYBiopsy at the moment of inclusion, before neoadjuvant chemotherapy | Procedure or surgery | FEC 100 + TAXOTERE |
| SURGERYSurgery after neoadjuvant chemotherapy | Procedure or surgery | FEC 100 + TAXOTERE |
Primary outcome
Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff
Time frame: 6 months
3 secondary outcomes
Correlation with node invasion
Time frame: 6 months
Correlation with basal, luminal phenotypes, HER2 status or hormonal status
Time frame: 6 months
Correlation with the response measured by ultrasound after chemotherapy
Time frame: After 3 and 5 months
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 17 Sep 2026.
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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.
BONNETERRE Jacques, MD, PhD principal investigator
Centre Oscar Lambret
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, BIOPSY and SURGERY in people with Breast Cancer, run by Centre Oscar Lambret at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Proteomic analysis by SELDI-TOF on the tumor biopsy and blood samples Histological response according To Chevallier and Sataloff (time frame: 6 months). 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 17 Sep 2026.