Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer
Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 21, 2013
CompletedFirst Posted
Study publicly available on registry
October 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedNovember 5, 2014
November 1, 2014
2.8 years
October 21, 2013
November 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The pathological complete response rate to two consequent induction preoperative chemotherapy regimens
After 18 weeks of induction chemotherapy
Secondary Outcomes (1)
Disease-free survival
3 years
Other Outcomes (1)
Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimens
After 18 weeks os induction chemotherapy
Study Arms (1)
2 consequent anthracycline-taxane based chemotherapy regimens
EXPERIMENTALPaclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks
Interventions
Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Russian Cancer Research Center named after N.N.Blokhin RAMS
Moscow, 115478, Russia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Research Associate of Department of Clinical Pharmacology and Chemotherapy
Study Record Dates
First Submitted
October 21, 2013
First Posted
October 24, 2013
Study Start
August 1, 2011
Primary Completion
May 1, 2014
Study Completion
September 1, 2014
Last Updated
November 5, 2014
Record last verified: 2014-11