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Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients

Primary Purpose

Triple-Negative Invasive Breast Carcinoma, Residual Tumor

Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Carmustine
Cyclophosphamide
Carboplatin
Autologous Hematopoietic Stem Cell Transplantation
Busulfan
Sponsored by
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-Negative Invasive Breast Carcinoma

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Triple Negative Breast Cancer diagnosis (no expression of hormonal receptors or Her2/neu)
  • Previous administration of neoadjuvant chemotherapy (60 days maximum)
  • No evidence of metastatic disease at inclusion
  • Residual tumor in the breast and/or lymph nodes
  • Normal renal, liver, heart, lung, and hematopoietic function

Exclusion Criteria:

  • Pregnancy
  • Disease progression during neoadjuvant therapy
  • Other tumors
  • Non triple negative breast cancer diagnosis
  • Pathological Complete Response achieved

Sites / Locations

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Unique

Arm Description

Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.

Outcomes

Primary Outcome Measures

Overall Survival
Time from diagnosis to death from any cause.

Secondary Outcome Measures

Disease Free Survival
Time from ending primary treatment to relapse of the disease.

Full Information

First Posted
January 28, 2016
Last Updated
January 10, 2020
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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1. Study Identification

Unique Protocol Identification Number
NCT02670109
Brief Title
Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients
Official Title
High-dose Chemotherapy With Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients Without Complete Pathological Response to Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Triple-negative breast cancer (TNBC) refers to any breast cancer that does not express estrogen receptor (ER), progesterone receptor (PR) or Her2/neu. Its incidence is approximately 180,000 cases per year. TNBC are known to be more aggressive with poor prognosis specially when no pathologic complete response (pCR) is achieved after neoadjuvant chemotherapy, with a higher risk of recurrence and a poor survival once that recurrence occurs. On the other hand, there is not a specific adjuvant or neoadjuvant treatment for these patients. Since autologous hematopoietic stem cell transplantation (HSCT) allows the usage of higher doses of chemotherapy, which results in higher cellular destruction with a decrease of hematological toxicity, it is proposed that this procedure is able to improve prognosis in TNBC patients with no pathologic complete response after neoadjuvant chemotherapy.
Detailed Description
Triple-negative breast cancer (TNBC) accounts for approximately 15%-25% of all breast cancer cases. TNBC are usually high-grade tumors, presented among younger women, African American and Hispanic women have a higher risk; generally in advanced stages when diagnosed, with visceral recurrence (liver, lung, brain). Standard treatment is surgery with adjuvant chemotherapy and radiotherapy. As a variation, neoadjuvant chemotherapy is very frequently used for triple-negative breast cancers, however, there is a lack of specific agents for this subset of patients, and, pathologic complete response does correlate with overall survival. At the moment, no optimal chemotherapy exists for TNBC patients who do not achieve a pCR. According to the German group, in the triple negative subset, 31% of patients with neoadjuvant chemotherapy achieved pathologic complete response (pCR), which correlates with progression free survival (HR 6.02 for those who do not achieve pCR), and an overall survival (HR 12.41 for those who do not achieve pCR). The usage of high-dose chemotherapy with autologous HSCT, is one of the therapies that have been studied in the patients with localized breast cancer aiming to improve its outcome. Autologous HSCT allows higher chemotherapy doses, which results in higher tumor cells destruction. Since 1980, several phase II studies were performed with high-dose chemotherapy and autologous HSCT, with an apparently initial benefit, thus this strategy was widely used outside controlled clinical trials. Afterward, the randomized studies did not show benefit in overall survival, causing this strategy to be abandoned. It is important to highlight studies heterogeneity by means of different treatment options in both experimental and control group, besides, advances in autologous HSCT has significantly reduced the complexity, mobility, and mortality related to the chemotherapy treatment. Two published studies including patients with localized TNBC, showed benefit in the progression free survival in the high-dose chemotherapy group, with a tendency to improved overall survival. One of them was performed by a german group, including patients with at least 9 positive nodes, which were randomized to receive two cycles of conventional dose chemotherapy followed by two cycles of high-dose chemotherapy with autologous HSCT versus four cycles of conventional dose chemotherapy followed by three cycles of dense dose chemotherapy, with granulocyte colony-stimulating factor (G-CSF) administration. Progression free survival was 76 months in the group of high dose chemotherapy versus 40.6 months in the conventional chemotherapy group, with an overall survival of 60 versus 44%, being statistically significant. Our hypothesis is that patients with TNBC with a high risk of recurrence (no pCR) who undergo high-dose chemotherapy followed by autologous HSCT will have a higher overall survival compared to those who do not undergo the above mentioned treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-Negative Invasive Breast Carcinoma, Residual Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unique
Arm Type
Experimental
Arm Description
Patients will receive a high dose chemotherapy regimen, consisting in the administration of three medications: Carmustine (BCNU) 300mg/m2 or Busulfan 16 mg/kg (according to availability), Cyclophosphamide 80mg/kg, and Carboplatin 1400/m2. Then they will undergo an Autologous Hematopoietic Stem Cell Transplantation.
Intervention Type
Drug
Intervention Name(s)
Carmustine
Other Intervention Name(s)
BCNU
Intervention Description
300mg/m2, IV, in 3 hours, during day -4
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Cytoxan
Intervention Description
80mg/kg, IV, in 2 hours, during two days -2, -3
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Description
1400/m2, IV, in 1 hour, during day -3
Intervention Type
Procedure
Intervention Name(s)
Autologous Hematopoietic Stem Cell Transplantation
Other Intervention Name(s)
Peripheral blood autologous HSCT
Intervention Description
Transfusion, in 3 hours, during day 0
Intervention Type
Drug
Intervention Name(s)
Busulfan
Other Intervention Name(s)
Myleran
Intervention Description
16mg/kg, Oral, during day -4
Primary Outcome Measure Information:
Title
Overall Survival
Description
Time from diagnosis to death from any cause.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Disease Free Survival
Description
Time from ending primary treatment to relapse of the disease.
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Triple Negative Breast Cancer diagnosis (no expression of hormonal receptors or Her2/neu) Previous administration of neoadjuvant chemotherapy (60 days maximum) No evidence of metastatic disease at inclusion Residual tumor in the breast and/or lymph nodes Normal renal, liver, heart, lung, and hematopoietic function Exclusion Criteria: Pregnancy Disease progression during neoadjuvant therapy Other tumors Non triple negative breast cancer diagnosis Pathological Complete Response achieved
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eucario Leon Rodriguez, M.D.
Phone
525554870900
Ext
2255
Email
eucarios@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Monica M Rivera Franco, M.D.,MSc
Phone
525554870900
Ext
2719
Email
monrif_90d@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eucario Leon Rodriguez, M.D.
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Monica M Rivera Franco, M.D.,MSc
Organizational Affiliation
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eucario Leon Rodriguez, M.D.
Phone
525554870900
Ext
2255
Email
eucarios@hotmail.com
First Name & Middle Initial & Last Name & Degree
Monica M Rivera Franco, M.D.
Phone
525554870900
Ext
2719
Email
monrif90d@gmail.com
First Name & Middle Initial & Last Name & Degree
Alejandra Armengol Alonso, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients

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