Clinical trial NCT01969032: Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer
Official title: Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Triple Negative Breast Cancer
Lead sponsor: Russian Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.

Detailed description: Compared to other breast cancer subtypes, patients with triple-negative breast cancer have a lower recurrence-free and overall survival, regardless of disease stage at diagnosis. That's why new approaches to treatment of this aggressive breast cancer subtype are extremely anticipated.

One of the ways to improve the results of treatment of locally advanced triple-negative breast cancer is intensification of induction preoperative chemotherapy regimens. Elevation of the rate of pathological complete responses after completion of intensification induction preoperative chemotherapy enables to decrease the stage and increase survival of this aggressive breast cancer subtype. We hope to achieve more clinical and pathological treatment responses than with standard chemotherapy regimens and therefore to improve treatment outcomes of this extremely adverse group of patients.

Eligibility criteria: Inclusion Criteria:

* Female patients, age ≥18 years≤75
* Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast
* Stages Т2-4 N 2-3 M0
* Signed inform consent

Exclusion Criteria:

* Previous treatment for this breast cancer
* History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease
* Pregnancy or breast-feeding
* Serious concurrent diseases or conditions that may alter chemotherapy conduction

Primary outcomes:
measure: The pathological complete response rate to two consequent induction preoperative chemotherapy regimens
timeFrame: After 18 weeks of induction chemotherapy
Secondary outcomes:
measure: Disease-free survival
timeFrame: 3 years
Other outcomes:
measure: Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimens
timeFrame: After 18 weeks os induction chemotherapy
Locations:
city: Moscow
country: Russian Federation
facility: Russian Cancer Research Center named after N.N.Blokhin RAMS
Study officials:
References: