Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focus… (NCT02806258) | Clinical Trial Compass
TerminatedPhase 1/2
Comparing Sequential Neoadjuvant Treatment Including Chemotherapy and Accelerated Radiation Focused to the Tumor Bed vs Neoadjuvant Chemotherapy Alone
France362 participantsStarted 2016-04-26
Plain-language summary
In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients ≥ 18 years of age
* Histologically confirmed invasive carcinoma of the breast
* Patient who desires breast conservation
* Tumor stage T1N1, T2-3 N0-1
* Operable BC for which an indication for CT is determined, including T1N1 and high risk T2-3 N0-1 tumors.
* Lobular and/or ductal invasive carcinoma
* Confirmation by imaging (standard +/- MRI) of unicentric and unilateral disease
* Luminal B (defined by hormone receptor positive and grade II-III (if available from core biopsy) and Ki67 ≥ 15% or by genomic analysis) and TNG subtypes
* HER2 negative
* No distant metastases
* No contraindication for PST with anthracycline and/or taxane based regimens
* Patients with no psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator with the aid of written information.
Exclusion Criteria:
* Patients considered too frail for CT whatever their age.
* Breast cancer clinical grade T4 and /or with major nodal involvement N2 (clinically, US, MRI or PET-CT).
* Lumpectomy is considered to be possible with an anticipated favourable cosmetic outcome considering the tumor size/breast size
* Multicentricity that would not allow BCS as confirmed by breast imaging
* Uni or bilateral inflammatory (T4d) BC
* Meta…
What they're measuring
1
PCR rates
Timeframe: At the end of chemotherapy: up to 21 weeks