Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Russian Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Mona Frolova, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01969032
First received: October 21, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  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.


Condition Intervention Phase
Triple Negative Breast Cancer
Drug: Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Two Consequent Chemotherapy Regimens as Induction Preoperative Therapy for Patients With Locally Advanced Triple Negative Breast Cancer

Resource links provided by NLM:


Further study details as provided by Russian Academy of Medical Sciences:

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 ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of patients with 3/4 Grade CTC adverse events to assess toxicity and tolerability of the chemotherapy regimens [ Time Frame: After 18 weeks os induction chemotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: August 2011
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969032

Contacts
Contact: Mona Frolova, PhD +74993241880 drfrolova@yandex.ru
Contact: Ekaterina Ignatova +74993241880 md.ignatova@gmail.com

Locations
Russian Federation
Russian Cancer Research Center named after N.N.Blokhin RAMS Recruiting
Moscow, Russian Federation, 115478
Contact: Mona Frolova, PhD    +74993241880    drfrolova@yandex.ru   
Contact: Ekaterina Ignatova    +74993241880    md.ignatova@gmail.com   
Principal Investigator: Mona Frolova, PhD         
Sponsors and Collaborators
Russian Academy of Medical Sciences
  More Information

Additional Information:
No publications provided

Responsible Party: Mona Frolova, Senior Research Associate of Department of Clinical Pharmacology and Chemotherapy, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01969032     History of Changes
Other Study ID Numbers: LATN-2ICR
Study First Received: October 21, 2013
Last Updated: October 21, 2013
Health Authority: Russia: Ethics Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Capecitabine
Doxorubicin
Paclitaxel
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 28, 2014