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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01969032
First Posted: October 24, 2013
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mona Frolova, Russian Academy of Medical Sciences
  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: Intervention Model: Single Group Assignment
Masking: None (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 Mona Frolova, 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 ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 3 years ]

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 ]

Enrollment: 41
Study Start Date: August 2011
Study Completion Date: September 2014
Primary Completion Date: May 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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01969032


Locations
Russian Federation
Russian Cancer Research Center named after N.N.Blokhin RAMS
Moscow, Russian Federation, 115478
Sponsors and Collaborators
Russian Academy of Medical Sciences
  More Information

Additional Information:
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
First Submitted: October 21, 2013
First Posted: October 24, 2013
Last Update Posted: November 5, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Liposomal doxorubicin
Albumin-Bound Paclitaxel
Capecitabine
Doxorubicin
Cyclophosphamide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents