Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Triple Negative Breast Cancer |
| Intervention | Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine |
| Phase | Phase 2 |
| Sponsor | Russian Academy of Medical Sciences |
| Responsible Party | Russian Academy of Medical Sciences |
| ClinicalTrials.gov Identifier | NCT01969032 |
| First Received | October 21, 2013 |
| Last Updated | October 21, 2013 |
| Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | October 21, 2013 |
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| Last Updated Date | October 21, 2013 |
| Start Date | August 2011 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | The pathological complete response rate to two consequent induction preoperative chemotherapy regimens [Time Frame: After 18 weeks of induction chemotherapy] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Disease-free survival [Time Frame: 3 years] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer |
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| Official Title | Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer |
| 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. |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Triple Negative Breast Cancer |
| Intervention | Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine 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 |
| Study Arm (s) | Experimental: 2 consequent anthracycline-taxane based chemotherapy regimens 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 |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
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| Estimated Enrollment | 40 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | January 2014 |
| 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 |
| Gender | Female |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Mona Frolova, PhD +74993241880 drfrolova@yandex.ru |
| Location Countries | Russian Federation |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01969032 |
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| Other Study ID Numbers | LATN-2ICR |
| Has Data Monitoring Committee | No |
| Information Provided By | Russian Academy of Medical Sciences |
| Study Sponsor | Russian Academy of Medical Sciences |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | October 2013 |
Locations[ + expand ][ + ]
| Russian Cancer Research Center named after N.N.Blokhin RAMS | Moscow, Russian Federation, 115478 Contact: Mona Frolova, PhD | +74993241880 | drfrolova@yandex.ruPrincipal Investigator: Mona Frolova, PhD Recruiting |
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