RANDOMIZED PHASE II/III STUDY OF INTENSIFIED ALKYLATING AGENT CHEMOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN THE PREOPERATIVE CHEMOTHERAPY OF BREAST TUMORS THAT ARE DEFICIENT FOR HOMOLOGOUS RECOMBINATION.

RANDOMIZED PHASE II/III STUDY OF INTENSIFIED ALKYLATING AGENT CHEMOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN THE PREOPERATIVE CHEMOTHERAPY OF BREAST TUMORS THAT ARE DEFICIENT FOR HOMOLOGOUS RECOMBINATION. - N06IAA: Intensive alkylating therapy in HRD breast cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30244

Enrollment

237

Registered

2006-12-14

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer mammary neoplasms

Interventions

All patients receive 3 courses of doxorubicin and cyclophosphamide, every 2 weeks with Filgrastim support (ddAC). Following this induction chemotherapy, the MRI is repeated to determine the presence

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Proven infiltrating breast cancer with either a primary tumor over 3 cm in size or cytologically proven spread to the axillary lymph nodes. Age 18 to 59 years. Performance status WHO 0 or 1. Adequate bone marrow, hepatic and renal functions.

Exclusion criteria

Exclusion criteria: 1. Previous radiation therapy or chemotherapy. 2. Other malignancies, except if treated 5 or more years ago with curative intent. 3. HER2/neu positivity. 4. Radionuclide ejection fraction below 50%. 5. Breast feeding or possible pregnancy.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the rate of pathological complete remission (pCR). The study will be stratified by subtype (basal like versus luminal tumors).	—

Secondary

Measure	Time frame
The secondary endpoints include: - the percentage of patients with tumors exhibiting signs of HRD; - the ability of intensified alkylating agent chemotherapy to induce pathological complete responses in patients who do not respond favorable to dose-dense AC; - recurrence free and overall survival	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)