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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant chemotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | two months after start of neoadjuvant chemotherapy |
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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)
Indication for neoadjuvant chemotherapy before breast-conserving surgery
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:
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:
No HIV positivity
Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne Valentin, MD | Institut Bergonié | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonie | Bordeaux | 33076 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer | The patient will be recruited during a multidisciplinary team meeting (MDT). 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. Neoadjuvant chemotherapy: as per standard practice |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer | The patient will be recruited during a multidisciplinary team meeting (MDT). 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. Neoadjuvant chemotherapy: as per standard practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Outcome could not be assessed. outcome was based on the assessment of MRI index by two radiologists. Only one radiologist assessed the index. | Posted | two months after start of neoadjuvant chemotherapy |
|
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer | The patient will be recruited during a multidisciplinary team meeting (MDT). 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. Neoadjuvant chemotherapy: as per standard practice |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simone Mathoulin-Pélissier, Director of Clinical Trials Unit | Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR | +33 5 56 33 33 33 | s.mathoulin@bordeaux.unicancer.fr |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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. | Outcome could not be assessed. outcome was based on the assessment of MRI index by two radiologists. Only one radiologist assessed the index. | Posted | two months after start of neoadjuvant chemotherapy |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |