Trials / Active Not Recruiting
Active Not RecruitingNCT01646034
High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer
High-dose Alkylating Chemotherapy in Oligo-metastatic Breast Cancer Harboring Homologous Recombination Deficiency
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates the effect of high-dose alkylating chemotherapy compared with standard chemotherapy as part of a multimodality treatment approach in patients with oligo-metastatic breast cancer harboring homologous recombination deficiency.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | carboplatin, thiotepa, and cyclophosphamide | tandem intermediate-dose alkylating therapy: carboplatin 800 mg/m2, thiotepa 240 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion. |
| DRUG | chemotherapy (docetaxel, doxorubicin, cyclofosfamide, carboplatin, paclitaxel, gemcitabine) | * chemotherapy naïve;three cycles of docetaxel, doxorubicin, and cyclofosfamide * chemotherapy naïve;1 cycle of dose-dense Adriamycin and cyclophosphamide followed by 4 cycles of carboplatin and paclitaxel * previously received anthracyclines without taxanes;three cycles of carboplatin and paclitaxel * previously received anthracyclines and taxanes;three cycles of carboplatin and gemcitabine |
Timeline
- Start date
- 2014-09-01
- Primary completion
- 2023-01-01
- Completion
- 2026-10-01
- First posted
- 2012-07-20
- Last updated
- 2022-10-12
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT01646034. Inclusion in this directory is not an endorsement.