Study on intensive chemotherapy in patients with breast cancer with 1 to 3 metastatic lesions. The breast tumor has to harbor homologous recombination deficiency

Phase 1

• Conditions: Oligo metastatic breast cancer harboring homologous recombination deficiency and/or the patient has a deleterious germline BRCA1 or BRCA2 mutation; MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000838-19-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-09
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 74

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.
• No prior line of chemotherapy for metastatic disease (a maximum of 3 months of palliative endocrine therapy is allowed).
• The tumor must be HER2-negative
• The tumor is deficient in homologous recombination and/or the patient has a deleterious germline BRCA1 or BRCA2 • 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)
• If clinically recommended LVEF =50% measured by echocardiography or MUGA
• Signed written informed consent
• Able to comply with the protocol

Are the trial subjects under 18? no
Number of subjects for this age range: 100
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 74
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Malignancy other than breast cancer, unless treated with curative intent and associated with long-term-survival probability >95%,including but not limited to basal cell carcinoma and papillary/follicular thyroid carcinoma. No second breast tumor.
• Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
• Concurrent anti-cancer treatment or investigational drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified