Date of publication: January, 2014
After promising results in a Phase 2 clinical trial, the investigational drug veliparib will be further evaluated in a Phase 3 clinical trial among women with early-stage triple-negative breast cancer. The trial will evaluate the addition of veliparib and carboplatin to standard neoadjuvant (before surgery) chemotherapy.
Neoadjuvant chemotherapy refers to chemotherapy that is given prior to surgery. This approach can make surgery easier to perform by shrinking or eliminating cancer prior to surgery. Neoadjuvant chemotherapy also provides information about how the cancer responds to chemotherapy. Women who have a complete response to neoadjuvant chemotherapy (a complete elimination of detectable cancer) tend to have better outcomes than women who do not have a complete response.
Veliparib is an investigational drug known as a PARP inhibitor. The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Drugs that inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy.
The Phase 3 clinical trial (NCT02032277) will enroll an estimated 624 women with early-stage triple-negative breast cancer. Study participants will be assigned to one of three treatment groups: standard neoadjuvant chemotherapy, standard neoadjuvant chemotherapy plus carboplatin, or standard neoadjuvant chemotherapy plus carboplatin and veliparib. The primary outcome of interest is how many women achieve a complete response to neoadjuvant chemotherapy.
Women who are interested in this study or other clinical trials are advised to talk with their doctor about eligibility criteria and potential risks and benefits.