Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According t… (NCT02339532) | Clinical Trial Compass
CompletedPhase 2
Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status
France86 participantsStarted 2015-01
Plain-language summary
The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen \[FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB\] and a non anthracycline-based regimen \[TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB\] according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression.
A very important objective of the study will be the evaluation of biomarkers that predict response to treatment.
Who can participate
Age range
18 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.
Inclusion Criteria:
* Women aged ≥ 18;
* Patient has histologically confirmed breast cancer, with a clinical tumour diameter of \> 1 cm (cT1c, cT2-3 or T4a)-
* Any N status
* No clinically or radiologically detectable metastases (M0);
* HR negative (both ER and PR \< 10% by IHC); for T1c status, otherwise HR negative or positive
* Her-2 positive (i.e. IHC score 3+ or FISH/SISH/CISH positive);
* Performance status ≤ 1 (according to WHO criteria);
* Patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy;
* Hæmatology: Absolute neutrophil count (ANC) ≥1,500/mm³; Platelets ≥100,000/mm³; Total white blood cell count (WBC) ≥3.000/mm³; Hb\> 9g/dl;
* Hepatic Function: Total bilirubin ≤1.5 time the upper normal limit (UNL); ASAT ≤ 1.5xUNL; ALAT ≤ 1.5xUNL; Alkaline phosphatase ≤ 2.5xUNL;
* Renal Function: Serum creatinine ≤1.5xUNL (and if Serum creatinine \>1.5xUNL, Creatinine clearance ≥50 mL/min (MDRD formula);
* Metabolic Function: Magnesium ≥ lower limit of normal; Calcium ≥ lower limit of normal;
* Patient with not controlled heart disease and for whom anthracyclines are not contraindicated. Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion;
* Patient agreeing to use effective contraception during and for ≥ 7 months after completion of study treatment;
* Patient able to comply with the protocol;
* Patient must have signed a written informed consent form prior to any study specific procedures;
* Patient …
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
Pathological complete response according to Chevallier classification