Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients
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| ClinicalTrials.gov Identifier: NCT02670109 |
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Recruitment Status :
Recruiting
First Posted : February 1, 2016
Last Update Posted : April 23, 2019
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| 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) |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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 |
- 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.
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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 2255 | eucarios@hotmail.com | |
| Contact: Monica M Rivera Franco, M.D. | 525554870900 ext 2254 | monrif_90d@hotmail.com |
| 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. | |
| Principal Investigator: | Eucario Leon Rodriguez, M.D. | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |