Breast Cancer
Conditions
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Brief 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. 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).
Interventions
DRUGNeoadjuvant 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.
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reproducibility of the MRI Vascular Permeability (Kep) | 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) | 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. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer | — |
|---|---|---|
| Age, Continuous | 47 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 16 participants | — |
| Sex: Female, Male Female | 16 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: two months after start of neoadjuvant chemotherapy
Population: Outcome could not be assessed. outcome was based on the assessment of MRI index by two radiologists. Only one radiologist assessed the index.
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.
Time frame: two months after start of neoadjuvant chemotherapy
Population: Outcome could not be assessed. outcome was based on the assessment of MRI index by two radiologists. Only one radiologist assessed the index.