Breast CancerISNA-SeinNCT00462696
MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer
A study testing Neoadjuvant chemotherapy in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
Trial summary
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neoadjuvant chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2006to 31 Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed infiltrative breast cancer meeting 1 of the following criteria:
- Operable T2 or T3, M0 disease
- Locally advanced disease (T4a, b, or c)
- No T4d disease
- Indication for neoadjuvant chemotherapy before breast-conserving surgery
- No desire by patient for complete mastectomy
- No overexpression of HER-2
- No multifocal tumor
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Life expectancy > 6 months
- No contraindication to MRI with contrast, including any of the following:
- Claustrophobia
- Prior major allergies
- Cardiac pacemaker
- Surgical clips
- Certain cardiac valves
- Sunken or hollow filters
- Implanted pump
- Cochlear implants
- Metallic foreign body (intra-ocular)
- No contraindication to chemotherapy or surgery
- No other serious condition that would preclude study therapy
- No other uncontrolled medical condition, including any of the following:
- Thyroid disease
- Neuropsychiatric disease
- Infection
- Insufficient coronary capacity
- NYHA class III-IV heart disease
- No HIV positivity
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy, radiotherapy, or surgery for ipsilateral breast cancer
- No prior biopsy of tumor before MRI
- No MRI at another center within the past 15 days
- No participation in another investigational study of anticancer therapy within the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in women receiving chemotherapy for infiltrating breast cancer.
Read the detailed description
Pilot study (feasibility) without direct individual benefit aimed at breast cancer patients treated with neoadjuvant chemotherapy prior to local breast surgery (lumpectomy or mastectomy).
- Conditions
- Breast Cancer
- Being tested
- Neoadjuvant chemotherapy
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC 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.
Neoadjuvant chemotherapyDrug
Neoadjuvant tehrapy as per standard practice :
Patients will be treated with six cycles of neoadjuvant chemotherapy combining epirubicin (75 mg/m² on day 1) and docetaxel (75 mg/m² on day 1), administered every 21 days (Delcambre, 2005; Wenzel, 1999). This treatment regimen is in line with the latest international recommendations (Kaufmann, 2003). The addition of a leukocyte growth factor in cases of grade IV leukopenia and/or treatment postponements due to grade 3-4 toxicity will be authorized with a maximum delay of 2 weeks per cycle. Dose reductions will be authorized in 25% increments for grade 3-4 toxicity
. Systematic surgical excision of the residual lesion (or the initial tumor site) will be performed between 22 and 35 days after the last chemotherapy treatment, in the form of a lumpectomy or mastectomy, depending on the residual tumor. Lymph node dissection will be systematically associated.
| Study group | Role | What they receive |
|---|---|---|
| Woment treated with neoadjuvant chemotherapy for breast cancer | Experimental | The patient will be recruited during a multidisciplinary team meeting (MDT) involving a medical oncologist, radiation oncologist, and surgeon. The histological diagnosis of invasive breast cancer will be confirmed based on the results of the micro-biopsy, which will be performed during the MDT meeting, after the initial MRI scan. The patient will submit her signed informed consent form. The MRI will be performed before the micro-biopsy so as not to distort the measurement of the tumor volume by a possible post-collection hematoma. Receives: Drug: Neoadjuvant chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of the MRI Vascular Permeability (Kep)
MRI vascular permeability is measured using Kep index (Rate constant between extracellular extravascular space (EES) and plasma).
Kep index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
Measured: two months after start of neoadjuvant chemotherapy
Reproducibility of the MRI Vascular Permeability (HA)
MRI vascular permeability is measured using HA index (Hepatic Artery index or Hepatic Arterial perfusion).
HA index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
Measured: two months after start of neoadjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startFeb 2006
- Primary completion31 Dec 2008
- Study completion31 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Valentin, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462696
- Sponsor's protocol ID
- IB-2005-37
- Acronym
- ISNA-Sein
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2007
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Contribution of MRI for the Evaluation of Early Response to Neoadjuvant Chemotherapy in Patients With Infiltrative Breast Cancer
- ClinicalTrials.gov ID
- NCT00462696
- Acronym / sponsor ID
- ISNA-Sein / IB-2005-37
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Feb 2006 (actual)
- Primary completion
- 31 Dec 2008 (actual)
- Study completion
- 31 Dec 2008 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help in learning how well chemotherapy works to kill breast cancer cells and allow doctors to plan better treatment. Drugs used in chemotherapy, such as epirubicin and docetaxel, may stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This clinical trial is studying MRI in evaluating early response to chemotherapy in women receiving chemotherapy for infiltrating breast cancer.
Detailed description
Pilot study (feasibility) without direct individual benefit aimed at breast cancer patients treated with neoadjuvant chemotherapy prior to local breast surgery (lumpectomy or mastectomy).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Woment treated with neoadjuvant chemotherapy for breast cancer | Experimental | Drug: Neoadjuvant chemotherapyThe patient will be recruited during a multidisciplinary team meeting (MDT) involving a medical oncologist, radiation oncologist, and surgeon. The histological diagnosis of invasive breast cancer will be confirmed based on the results of the micro-biopsy, which will be performed during the MDT meeting, after the initial MRI scan. The patient will submit her signed informed consent form. The MRI will be performed before the micro-biopsy so as not to distort the measurement of the tumor volume by a possible post-collection hematoma. |
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| Neoadjuvant chemotherapyNeoadjuvant tehrapy as per standard practice : Patients will be treated with six cycles of neoadjuvant chemotherapy combining epirubicin (75 mg/m² on day 1) and docetaxel (75 mg/m² on day 1), administered every 21 days (Delcambre, 2005; Wenzel, 1999). This treatment regimen is in line with the latest international recommendations (Kaufmann, 2003). The addition of a leukocyte growth factor in cases of grade IV leukopenia and/or treatment postponements due to grade 3-4 toxicity will be authorized with a maximum delay of 2 weeks per cycle. Dose reductions will be authorized in 25% increments for grade 3-4 toxicity . Systematic surgical excision of the residual lesion (or the initial tumor site) will be performed between 22 and 35 days after the last chemotherapy treatment, in the form of a lumpectomy or mastectomy, depending on the residual tumor. Lymph node dissection will be systematically associated. | Drug | Woment treated with neoadjuvant chemotherapy for breast cancer |
Primary outcome
Reproducibility of the MRI Vascular Permeability (Kep)
Time frame: two months after start of neoadjuvant chemotherapy
MRI vascular permeability is measured using Kep index (Rate constant between extracellular extravascular space (EES) and plasma). Kep index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
Reproducibility of the MRI Vascular Permeability (HA)
Time frame: two months after start of neoadjuvant chemotherapy
MRI vascular permeability is measured using HA index (Hepatic Artery index or Hepatic Arterial perfusion). HA index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Fabienne Valentin, MD study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoadjuvant chemotherapy in people with Breast Cancer, run by Institut Bergonié 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 6 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reproducibility of the MRI Vascular Permeability (Kep) (time frame: two months after start of neoadjuvant chemotherapy). The study lists 2 primary outcomes in all. 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 6 Oct 2025.