Pre-Operative PARPi and Irradiation (POPI) in Women with an Incomplete Response to Neo Adjuvant Chemotherapy (NAC) for Breast Cancer.
Investigating the Safety and Side Effects of Combining Investigational Medication with Radiation for Breast Cancer
Brief description of study.
The purpose of this study is to determine the number of participants who can handle the treatment within specific safety parameters, determine the number of participants who can handle safely the maximum tolerated dose (MTD) (within 50-200 mg/BID dose range) when combining Veliparib and radiation, as well as to identify side effects and their intensity at different dosing levels.
Detailed description of study
The purpose of this study is to identify the side effects, if any, when radiation and Veliparib are given together to treat women who still have cancer in their breast or under arm lymph nodes after being treated with pre-surgery chemotherapy.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: breast cancer,cancer,oncology
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Age: 18 years - 100 years
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Gender: Female
Inclusion Criteria
Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast with confirmed nodal metastasis
Patients must have an axillary nodal evaluation by fine needle aspiration (FNA), sentinel node biopsy (SNB) or nodal dissection
Patient must have had a bilateral mammogram prior to NAC unless there is only one breast
Patient must have a Medical Oncology consult and be recommended to receive neoadjuvant chemotherapy for a stage IIB through IV carcinoma
Patients must not have received prior radiation therapy to the involved breast at any time for any reason
Patient must have a history and physical within 2 weeks prior to the start of any protocol therapy (radiation and veliparib)
Patient must have > 1.0 cm residual in-breast cancer and/or clinically positive residual nodal disease
No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years
Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment
Patients must have a performance status 0 or 1 by ECOG criteria (Appendix I)
Exclusion Criteria
Patients with squamous, or metaplastic carcinomas or sarcomas of the breast
Women who have a investigational therapy, was less than 14 days prior to protocol therapy (radiation and veliparib)
Bisphosphonates, hormone modification therapy, and trastuzumab are permitted without restriction
Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or prior anti-cancer treatment
Pregnant or breast-feeding
Clinically significant and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal, hematologic or neurological/psychiatric disease or disorder
Unable to swallow and retain oral medications
History of seizure disorder
Known contraindication to enhanced MRI and CT
Previous enrollment on another study involving the investigation of veliparib (ABT- 888), with the exception of receiving a single dose of study drug
Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive veliparib (ABT-888) and/or breast irradiation
This study investigates the safety and side effects of combining an investigational medication with radiation for treating women with breast cancer. Specifically, it focuses on women who still have cancer in their breast or underarm lymph nodes after receiving chemotherapy before surgery. The study aims to find out how many participants can handle the treatment safely and to determine the maximum dose that can be tolerated.
Participants in the study will undergo procedures that include receiving a combination of the investigational medication and radiation therapy. The study will monitor participants for any side effects and their intensity at different dosing levels to ensure safety.
- Who can participate: Women with confirmed adenocarcinoma of the breast and nodal metastasis who have not received prior radiation therapy to the affected breast are eligible. Participants must have a performance status of 0 or 1 by ECOG criteria and should not have any serious medical or psychiatric illness that prevents informed consent. Additionally, participants need a Medical Oncology consult and a recommendation for neoadjuvant chemotherapy to meet eligibility criteria.
- Study details: Participants will receive a combination of the investigational medication and radiation therapy. The study will assess the safety of this combination and monitor for side effects. A placebo is not used in this study.
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