High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Breast Cancer |
Intervention | Drug: carboplatin, thiotepa, and cyclophosphamide Drug: chemotherapy (docetaxel, doxorubicin, cyclofosfamide, carboplatin, paclitaxel, gemcitabine) |
Phase | Phase 3 |
Sponsor | The Netherlands Cancer Institute |
Responsible Party | The Netherlands Cancer Institute |
ClinicalTrials.gov Identifier | NCT01646034 |
First Received | June 14, 2012 |
Last Updated | June 25, 2013 |
Last verified | June 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | June 14, 2012 |
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Last Updated Date | June 25, 2013 |
Start Date | July 2012 |
Estimated Primary Completion Date | July 2019 |
Current Primary Outcome Measures | Event free survival [Time Frame: assessed up to 120 months] [Designated as safety issue: No]time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer |
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Official Title | High-dose Alkylating Chemotherapy in Oligo-metastatic Breast Cancer Harboring Homologous Recombination Deficiency |
Brief 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Breast Cancer |
Intervention | 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 previously received anthracyclines without taxanes;three cycles of carboplatin and paclitaxel previously received anthracyclines and taxanes;three cycles of carboplatin and gemcitabine |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 86 |
Estimated Completion Date | July 2019 |
Estimated Primary Completion Date | July 2017 |
Eligibility Criteria | Inclusion Criteria: - Histologically or cytologically confirmed infiltrating breast cancer - Oligometastatic disease defined as one to three metastatic lesions, with or without primary tumor, local recurrence, or locoregional lymph node metastases, including the axillary, parasternal, and ipsilateral periclavicular regions. All lesions must be amenable to resection or radiotherapy with curative intent. Staging examinations must have included a PET-scan plus diagnostic CT-scan of the chest and abdomen, and an isotope bone scan. When the isotope bone scan is doubtful and plain radiographs do not explain the abnormality, MRI or CT-scan of the affected skeletal region must be performed. - The tumor must be HER2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization in case of score 2 or 3 at immunohistochemistry). - The tumor must be ER positive (≥ 10% nuclear staining at IHC) and poorly differentiated (grade 3). or ER negative; the rare tumors that are ER-negative and PgR-positive will be eligible, if this pattern of hormone receptor expression can be verified in the NKI-AVL reference pathology lab. - Known BRCA1 or BRCA2 mutation carriers are eligible regardless of the estrogen receptor status of their tumor. - Age ≥ 18 years - World Health Organisation (WHO) performance status 0 or 1 - Adequate bone marrow function (ANC ≥ 1.0 x 109/l, platelets ≥ 100 x 109/l) - Adequate hepatic function (ALAT, ASAT and bilirubin ≤ 2.5 times upper limit of normal) - Adequate renal function (creatinine clearance ≥ 60 ml/min) - LVEF ≥ 50% measured by echocardiography or MUGA - Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule - Signed written informed consent - Able to comply with the protocol Exclusion Criteria: - No malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy - No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection. - No concurrent anti-cancer treatment or investigational drugs |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Gabe S Sonke, MD +3120512 g.sonke@nki.nl |
Location Countries | Netherlands |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01646034 |
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Other Study ID Numbers | N12OLG |
Has Data Monitoring Committee | No |
Information Provided By | The Netherlands Cancer Institute |
Study Sponsor | The Netherlands Cancer Institute |
Collaborators | Not Provided |
Investigators | Principal Investigator: Gabe S Sonke, MD NKI-AVL, Amsterdam |
Verification Date | June 2013 |
Locations[ + expand ][ + ]
NKI-AVL | Amsterdam, Netherlands, 1066 CX Contact: Gabe S Sonke, MD | +31205122570 | g.sonke@nki.nlPrincipal Investigator: Gabe S Sonke, MD Recruiting |
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