Clinical trial · Interventional
Autologous Hematopoietic Stem Cell Transplantation as Adjuvant Treatment for Triple Negative Breast Cancer Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Residual Tumor | Neoplasm | CURATED_BROADER | 0.78 |
| Triple-Negative Invasive Breast Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous Hematopoietic Stem Cell Transplantation | Procedure | — | UNRESOLVED |
| Busulfan | Drug | Busulfan | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Carmustine | Drug | Carmustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Unique
- 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.
- interventionNames
- Drug: Carmustine
- Drug: Cyclophosphamide
- Drug: Carboplatin
- Procedure: Autologous Hematopoietic Stem Cell Transplantation
- Drug: Busulfan
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- One year
- description
- Time from diagnosis to death from any cause.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available