breast cancer mammary neoplasms
Conditions
Interventions
Following diagnosis, informed consent, and baseline investigations, all
patients receive three cycles of induction chemotherapy depending on previously
received agents. Patients who:
* are chemother
Sponsors
Nederlands Kanker Instituut
Eligibility
Age
18 Years to 99 Years
Inclusion 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 [CISH or FISH] in case of score 2 or 3 at immunohistochemistry). - The tumor must be ER and PgR negative (
Exclusion criteria
Exclusion criteria: - Malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy - Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection. - Concurrent anti-cancer treatment or investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the three-year progression-free survival after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: * Difference in three-year progression-free survival between high-dose alkylating chemotherapy compared with standard chemotherapy in patients whose tumor harbors HRD * Difference in percentage of patients with complete remission after high-dose alkylating chemotherapy compared with standard chemotherapy in patients whose tumor harbors HRD * Difference in median progression-free survival between the two treatment arms * Difference in median overall survival (time from start of treatment to death from any cause) * Difference in three-year progression-free survival between patients with and without HRD * Difference in percentage of patients with grade >2 hematological toxicity (CTCAE v4.0) * Difference in percentage of patients with grade >2 non-hematological toxicity (CTCAE v4.0) | — |
Countries
Netherlands
Outcome results
None listed