Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02670109|
Recruitment Status : Recruiting
First Posted : February 1, 2016
Last Update Posted : January 14, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
300mg/m2, IV, in 3 hours, during day -4
Other Name: BCNU
80mg/kg, IV, in 2 hours, during two days -2, -3
Other Name: Cytoxan
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
16mg/kg, Oral, during day -4
Other Name: Myleran
- Overall Survival [ Time Frame: One year ]Time from diagnosis to death from any cause.
- Disease Free Survival [ Time Frame: One year ]Time from ending primary treatment to relapse of the disease.
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
|Contact: Eucario Leon Rodriguez, M.D.||525554870900 ext email@example.com|
|Contact: Monica M Rivera Franco, M.D.,MSc||525554870900 ext firstname.lastname@example.org|
|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 email@example.com|
|Contact: Monica M Rivera Franco, M.D. 525554870900 ext 2719 firstname.lastname@example.org|
|Sub-Investigator: Alejandra Armengol Alonso, M.D.|
|Principal Investigator:||Eucario Leon Rodriguez, M.D.||Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|
|Principal Investigator:||Monica M Rivera Franco, M.D.,MSc||Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|