Veliparib With Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:12/17/2017
Start Date:January 2012
End Date:October 2017

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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

The purpose of this study is to determine the maximum tolerated dose of veliparib that can be
given while a patient is receiving radiation therapy.

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 treatment.

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 treatment).

- 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 document.

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
permissible).

- 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 veliparib.

- 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).
We found this trial at
5
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Durham, North Carolina 27710
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Houston, Texas 77030
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Houston, TX
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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