Breast CancerPhase 1NCT01477489
Veliparib With Radiation Therapy in Patients With Inflammatory or Loco-regionally Recurrent Breast Cancer
A Phase 1 study testing Veliparib and Standard radiation treatment in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 5 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Veliparib and Standard radiation treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2012to Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48109
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Duke
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Veliparib, Standard radiation treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VeliparibDrug
Starting dose of veliparib will be 50 mg taken twice daily and will escalate up to a possible 200 mg twice daily.
Standard radiation treatmentRadiation
Limited to 60 Gy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Veliparib; Radiation: Standard radiation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-24 months
Secondary outcomes (1)
To describe the nature of toxicity that develops when PARP inhibitors are administered concurrently with chest wall radiotherapy.
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionOct 2014
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reshma Jagsi, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477489
- Sponsor's protocol ID
- UMCC 2011.087
- Status last verified
- Dec 2017
- First submitted
- 18 Nov 2011
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jagsi R, Griffith KA, Bellon JR, Woodward WA, Horton JK, Ho A, Feng FY, Speers C, Overmoyer B, Sabel M, Schott AF, Pierce L; Translational Breast Cancer Research Consortium. Concurrent Veliparib With Chest Wall and Nodal Radiotherapy in Patients With Inflammatory or Locoregionally Recurrent Breast Cancer: The TBCRC 024 Phase I Multicenter Study. J Clin Oncol. 2018 May 1;36(13):1317-1322. doi: 10.1200/JCO.2017.77.2665. Epub 2018 Mar 20.
PubMed 29558281
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01477489
- Acronym / sponsor ID
- UMCC 2011.087
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Veliparib, Radiation: Standard radiation treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VeliparibStarting dose of veliparib will be 50 mg taken twice daily and will escalate up to a possible 200 mg twice daily. | Drug | Treatment |
| Standard radiation treatmentLimited to 60 Gy. | Radiation | Treatment |
Primary outcome
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.
Time frame: 12-24 months
1 secondary outcome
To describe the nature of toxicity that develops when PARP inhibitors are administered concurrently with chest wall radiotherapy.
Time frame: 12-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
- Derived from this study: PubMed 29558281Jagsi R, Griffith KA, Bellon JR, Woodward WA, Horton JK, Ho A, Feng FY, Speers C, Overmoyer B, Sabel M, Schott AF, Pierce L; Translational Breast Cancer Research Consortium. Concurrent Veliparib With Chest Wall and Nodal Radiotherapy in Patients With Inflammatory or Locoregionally Recurrent Breast Cancer: The TBCRC 024 Phase I Multicenter Study. J Clin Oncol. 2018 May 1;36(13):1317-1322. doi: 10.1200/JCO.2017.77.2665. Epub 2018 Mar 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reshma Jagsi, MD principal investigator
University of Michigan
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Veliparib and Standard radiation treatment in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: 12-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477489, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.