An interventional study of Neoadjuvant chemotherapy in Breast Cancer, sponsored by Institut Bergonié. Completed at 1 site in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-10-06.
Sponsored by Institut Bergonié · Not applicable, Interventional, and Diagnostic
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.
Pilot study (feasibility) without direct individual benefit aimed at breast cancer patients treated with neoadjuvant chemotherapy prior to local breast surgery (lumpectomy or mastectomy).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 16 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed infiltrative breast cancer meeting 1 of the following criteria:
Locally advanced disease (T4a, b, or c)
Indication for neoadjuvant chemotherapy before breast-conserving surgery
PATIENT CHARACTERISTICS:
No contraindication to MRI with contrast, including any of the following:
No other uncontrolled medical condition, including any of the following:
PRIOR CONCURRENT THERAPY:
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.
Drug: Neoadjuvant chemotherapy
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.
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.
Time frame: 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.
Time frame: two months after start of neoadjuvant chemotherapy
| Milestone | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer |
|---|---|
| Started | 16 |
| Completed | 16 |
| Not completed | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer | — | — | — |
| Age, Continuous(years) | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer |
|---|---|
| Median | 47 (38 to 63) |
| Sex: Female, Male(Participants) | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer |
|---|---|
| Female | 16 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer |
|---|
| Region of Enrollment(participants) | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer |
|---|---|
| France | 16 |
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Institut Bergonié