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A Phase 1 Study of Veliparib Administered Concurrently With Chest Wall and Nodal Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer

Phase 1
19 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase 1 Study of Veliparib Administered Concurrently With Chest Wall and Nodal Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer

Veliparib is an investigational drug known as a "PARP inhibitor." Because veliparib affects
the way that cells repair damage, veliparib may be useful in combination with radiation
treatment because it may help make radiation work better. Veliparib is an oral medication
that will be taken twice daily during the 6 weeks a patient is receiving radiation therapy.
The researchers will also be analyzing blood and tissue taken from the skin of patients.
The skin biopsies will help determine which patients are more sensitive to treatment with
radiation combined with the study drug. While the blood sample will allow researchers to
see if the way a person's body processes drugs affects how the patient responds to

Inclusion Criteria:

- Histologically confirmed breast cancer with either a) locoregional recurrence after
previous mastectomy or b) inflammatory breast cancer status post mastectomy for which
radiotherapy to the chest wall and regional nodes is planned as part of treatment.
Patients with Stage IV disease are eligible as long as they meet these criteria.

- Surgical resection of disease and willingness to wait at least three weeks after
surgery to begin radiotherapy.

- Willingness to discontinue any cytotoxic chemotherapeutic agents, immunotherapy,
biologic therapy, and targeted therapies (including trastuzumab) at least two weeks
prior to start of radiotherapy.

- Age >18 years.

- ECOG performance status <2 (Karnofsky >60%, see Appendix A).

- Life expectancy of greater than 6 months.

- Adequate hematologic, renal and hepatic function (assessed within the two weeks prior
to registration and within the month prior to the commencement of protocol

- Negative pregnancy test (within two weeks prior to registration) if woman has
child-bearing potential (defined as not having undergone surgical methods of
sterilization and having had menses within the past year).

- Ability to swallow and retain oral medications.

- Willingness to undergo the three required skin punch biopsies for research purposes.

- Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Radiation therapy: Prior history of radiation therapy to the chest wall and/or
regional nodes is not allowed (but prior radiation therapy to other sites is

- Breast reconstruction: Patients who have undergone breast reconstruction procedures
after mastectomy are excluded because of concerns about additional toxicity in this
patient population.

- Gross residual tumor or positive microscopic margins: Patients with gross residual
tumor or positive microscopic margins will not be eligible because radiation dose in
this study will be limited to 60Gy.

- Ongoing therapy with other investigational agents: Patients may not be receiving any
other investigational agents.

- Unresolved toxicity from other agents: Patients with unresolved or unstable, CTCAE
v4 Grade 3 or greater toxicity from prior administration of another investigational
drug and/or prior anti-cancer treatment are not eligible.

- Significant comorbidity: Also ineligible are patients with clinically significant
and uncontrolled major cardiac, respiratory, renal, hepatic, gastrointestinal,
hematologic or neurological/psychiatric disease or disorder, including but not
limited to: active uncontrolled infection; symptomatic congestive heart failure,
unstable angina pectoris, or cardiac arrhythmia; any other illness condition(s) that
could exacerbate potential toxicities, confound safety assessments, require excluded
therapy for management, or limit compliance with study requirements.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to veliparib.

- Concomitant anti-neoplastic treatment is not allowed during protocol treatment and
should be completed at least 2 weeks prior to commencement of protocol treatment,
with resolution of any associated acute toxicities, except that endocrine therapies
and bisphosphonates are permitted without restriction even during protocol treatment.

- Pregnant women are excluded from this study because radiation therapy has teratogenic
and abortifacient effects. Because there is an unknown but potential risk for
adverse events in nursing infants secondary to treatment of the mother with
veliparib, breastfeeding should be discontinued before the patient receives

- Patients with active seizure disorder or history of seizure, as well as patients with
CNS metastases (unless CNS metastases have been stable after therapy for >3 months
and the patient is not on steroids at the time of study enrollment).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose of veliparib that can be administered concurrently with standard doses of radiotherapy to the chest wall and regional nodes.

Outcome Time Frame:

12-24 months

Safety Issue:


Principal Investigator

Reshma Jagsi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Food and Drug Administration

Study ID:

UMCC 2011.087



Start Date:

January 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



University of MichiganAnn Arbor, Michigan  48109-0624
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
MD Anderson Cancer CenterHouston, Texas  77030-4096
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
DukeDurham, North Carolina  27710