Study on intensive chemotherapy in patients with breast cancer with 1 to 3 metastatic lesions. The breast tumor has to be hormonal receptor negative and HER2 negative.

• Conditions: Oligo metastatic triple negative or BRCA1/1 like breast cancer; MedDRA version: 13.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-001237-16-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

1.Histologically or cytologically confirmed infiltrating breast cancer
2.Oligometastatic disease defined as one to three distant 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.
3.The tumor must be HER2/neu-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 or 3 at immunohistochemistry).
4.The tumor must be ER and PgR negative (<10% nuclear staining at IHC) unless the patient is a known BRCA1 or BRCA2 mutation carrier. 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.
5.Age =18 years
6.World Health Organisation (WHO) performance status 0 or 1
7.Adequate bone marrow function (ANC =1.0 x 109/l, platelets =100 x 109/l)
8.Adequate hepatic function (ALAT, ASAT and bilirubin =2.5 times upper limit of normal)
9.Adequate renal function (creatinine clearance =60 ml/min)
10.LVEF =50% measured by echocardiography or MUGA
11.Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
12.Signed written informed consent
13.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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.No malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy
2.No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
3.No concurrent anti-cancer treatment or investigational drugs

Study & Design

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