MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer (NCT00462696) | Clinical Trial Compass
CompletedNot Applicable
MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer
France16 participantsStarted 2006-02
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ther…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reproducibility of the MRI Vascular Permeability (Kep)
Timeframe: two months after start of neoadjuvant chemotherapy
2
Reproducibility of the MRI Vascular Permeability (HA)
Timeframe: two months after start of neoadjuvant chemotherapy