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Trial record 91 of 193 for:    Oral Cancer | ( Map: Mexico )

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

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ClinicalTrials.gov Identifier: NCT02670109
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Condition or disease Intervention/treatment Phase
Triple-Negative Invasive Breast Carcinoma Residual Tumor Drug: Carmustine Drug: Cyclophosphamide Drug: Carboplatin Procedure: Autologous Hematopoietic Stem Cell Transplantation Drug: Busulfan Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Unique

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.

Drug: Carmustine
300mg/m2, IV, in 3 hours, during day -4
Other Name: BCNU

Drug: Cyclophosphamide
80mg/kg, IV, in 2 hours, during two days -2, -3
Other Name: Cytoxan

Drug: Carboplatin
1400/m2, IV, in 1 hour, during day -3
Other Name: Paraplatin

Procedure: Autologous Hematopoietic Stem Cell Transplantation
Transfusion, in 3 hours, during day 0
Other Name: Peripheral blood autologous HSCT

Drug: Busulfan
16mg/kg, Oral, during day -4
Other Name: Myleran




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: One year ]
    Time from diagnosis to death from any cause.


Secondary Outcome Measures :
  1. Disease Free Survival [ Time Frame: One year ]
    Time from ending primary treatment to relapse of the disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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): NCT02670109


Contacts
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Contact: Eucario Leon Rodriguez, M.D. 525554870900 ext 2255 eucarios@hotmail.com
Contact: Monica M Rivera Franco, M.D. 525554870900 ext 2254 monrif_90d@hotmail.com

Locations
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Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Recruiting
Mexico City, Distrito Federal, Mexico, 14080
Contact: Eucario Leon Rodriguez, M.D.    525554870900 ext 2255    eucarios@hotmail.com   
Contact: Monica M Rivera Franco, M.D.    525554870900 ext 2719    monrif90d@gmail.com   
Sub-Investigator: Alejandra Armengol Alonso, M.D.         
Sponsors and Collaborators
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Investigators
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Principal Investigator: Eucario Leon Rodriguez, M.D. Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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Responsible Party: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
ClinicalTrials.gov Identifier: NCT02670109     History of Changes
Other Study ID Numbers: INCMNSZ REF 1239
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasm, Residual
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Cyclophosphamide
Busulfan
Carmustine
Carboplatin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists