High Dose Chemotherapy in Oligo-metastatic Homologous Recombination Deficient Breast Cancer (Oligo)

  • STATUS
    Recruiting
  • End date
    Oct 8, 2026
  • participants needed
    74
  • sponsor
    The Netherlands Cancer Institute
Updated on 8 April 2022
paclitaxel
cyclophosphamide
endocrine therapy
doxorubicin
anthracyclines
metastasis
carboplatin
hormone therapy
immunohistochemistry
HER2
primary tumor
docetaxel
stage iv breast cancer
erbb2
invasive breast cancer
BRCA1
BRCA2
mammogram
adriamycin

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.

Details
Condition Breast Cancer
Treatment carboplatin, thiotepa, and cyclophosphamide, chemotherapy (docetaxel, doxorubicin, cyclofosfamide, carboplatin, paclitaxel, gemcitabine)
Clinical Study IdentifierNCT01646034
SponsorThe Netherlands Cancer Institute
Last Modified on8 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed infiltrating breast cancer
Oligometastatic disease defined as one to three distant metastatic lesions, with or without primary tumor, local recurrence, or locoregional lymph node metastases, including the ipsilateral axillary, parasternal, and periclavicular regions. All lesions must be amenable to resection or radiotherapy with curative intent. Staging examinations must have included a PET-CT-scan and a MRI of the liver in case of liver metastases. Clustered lymph nodes that can be irradiated with curative intent in a single field are defined as a single lesion. Histologic or cytologic confirmation of at least one distant metastatic lesion is required
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 (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization in case of score 2 or 3 at immunohistochemistry)
The tumor is deficient in homologous recombination and/or the patient has a deleterious germline BRCA1 or BRCA2 mutation
At least stable disease of all tumor lesions after three courses of induction chemotherapy
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 echocardiography, MUGA, or MRI to evaluate if LVEF ≥50%
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
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