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Neoadjuvant study of niraparib in patients with HER2-negative, BRCA-mutated, resectable breast cancer
Laura M Spring1, Hyo Han2, Minetta C Liu3
1Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA.
Abstract:
This single-arm pilot study (NCT03329937) evaluated neoadjuvant niraparib antitumor activity and safety in patients with localized HER2-negative, BRCA-mutated breast cancer. Twenty-one patients received niraparib 200 mg once daily in 28-day cycles. After 2 cycles, tumor response (≥30% reduction from baseline) by MRI was 90.5% and 40.0% (6 of 15) of patients who received only niraparib (2-6 cycles) had pathological complete response; no new safety signals were identified. High niraparib intratumoral concentration was observed.
Insights
Neoadjuvant niraparib showed high antitumor activity in patients with HER2-negative, BRCA-mutated breast cancer. The study found a 90.5% tumor response rate and acceptable safety, with high drug concentration in tumors.
Area of Science:
- Oncology
- Pharmacology
- Genetics
Background:
- Breast cancer remains a significant health concern, particularly HER2-negative subtypes.
- BRCA mutations are key drivers in certain breast cancer types, influencing treatment strategies.
- Neoadjuvant therapy aims to shrink tumors before surgery, improving outcomes.
Purpose of the Study:
- To evaluate the neoadjuvant antitumor activity of niraparib.
- To assess the safety and tolerability of niraparib in this patient population.
- To determine niraparib's intratumoral concentration.
Main Methods:
- A single-arm pilot study involving 21 patients with localized HER2-negative, BRCA-mutated breast cancer.
- Patients received niraparib 200 mg once daily for 28-day cycles.
- Tumor response assessed by MRI after 2 cycles; pathological complete response evaluated post-treatment.
Main Results:
- A 90.5% objective tumor response rate was observed by MRI after 2 cycles.
- 40.0% of patients achieved pathological complete response.
- No new safety signals were identified, and high intratumoral niraparib concentrations were noted.
Conclusions:
- Neoadjuvant niraparib demonstrates promising antitumor activity and a favorable safety profile in HER2-negative, BRCA-mutated breast cancer.
- High drug concentrations within tumors suggest effective target engagement.
- Further investigation in larger trials is warranted.
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