Breast CancerPhase 2NCT01074970
PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
A Phase 2 study testing Cisplatin and Rucaparib in people with Breast Cancer, run by Hoosier Cancer Research Network at 27 sites in United States.
Trial summary
The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cisplatin and Rucaparib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 27 sitesUnited States
- Study dates
- Feb 2010to 15 Dec 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, stage I-III at diagnosis (AJCC 6th edition) based on initial evaluation by clinical examination and/or breast imaging. NOTE: Patients with ER+ and/or PR+ may enroll ONLY if they are known carriers of a deleterious mutation in BRCA1 or BRCA2. Patients with HER2+ tumors may not enroll regardless of BRCA status.
- Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Patients may NOT have received cisplatin as part of their neoadjuvant therapy regimen. Patients who received preoperative therapy as part of a clinical trial may enroll. No adjuvant chemotherapy after surgery other than that specified in this protocol is allowed. Adjuvant bisphosphonate use is allowed.
- Must have completed definitive resection of primary tumor. The last surgery for breast cancer must have been completed at least 14 days prior to registration for protocol therapy.
- Must have significant residual invasive disease at the time of definitive surgery following preoperative chemotherapy. Significant residual disease is defined at least one of the following:
- Miller-Payne response in the breast of 0-25.
- Residual Cancer Burden (RBC) classification II or III6
Show all 16Show fewer
- Residual carcinoma in one or more regional lymph nodes that would meet AJCC 6th edition criteria for N1 - N3 disease.
- Alternatively, if Miller-Payne or RCB grading is not available, the patient will be eligible if the pathology report indicates that the area of residual invasive disease in the breast measures at least 2 cm following preoperative therapy. The presence of DCIS without invasion does not qualify as residual disease in the breast.
- Whole breast radiotherapy is required for patients who underwent breast conserving therapy, including lumpectomy or partial mastectomy. Patients receiving adjuvant radiation therapy must have completed radiotherapy at least 14 days prior to registration for protocol therapy.
- Written informed consent and HIPAA authorization for release of personal health information.
- Age > 18 years at the time of consent.
- Must consent to allow submission of archived tumor tissue sample from definitive surgery.
- Must consent to collection of blood samples for PK analysis.
- Women of childbearing potential and males must be willing to use an effective method of contraception from the time consent is signed until 4 weeks after treatment discontinuation.
- Women of childbearing potential must have a negative pregnancy test within 14 days prior to registration for protocol therapy.
- Women must not be breastfeeding.
Who cannot join
- No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease.
- No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No history of chronic hepatitis B or C
- No clinically significant infections as judged by the treating investigator.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Presbyterian Medical Group
Albuquerque, New Mexico, 87110
University of New Mexico Cancer Center: Albuquerque
Albuquerque, New Mexico, 87131
HOPE a Women's Cancer Center
Asheville, North Carolina, 28806
University of Colorado Cancer Center
Aurora, Colorado, 80045
The Center for Cancer & Hematologic Disease
Cherry Hill, New Jersey, 08003
Seidman Cancer Center
Cleveland, Ohio, 44106
Fort Wayne Oncology & Hematology, Inc
Fort Wayne, Indiana, 46815
St. Jude Heritage Healthcare
Fullerton, California, 92835
Pinnacle Health Fox Chase Regional Cancer Center
Harrisburg, Pennsylvania, 17110
Memorial Cancer Institute Breast Cancer Center
Hollywood, Florida, 33021
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Community Regional Cancer Center
Indianapolis, Indiana, 46256
Horizon Oncology Research, Inc./IU Health Arnett
Lafayette, Indiana, 47905
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128
University of California Los Angeles
Los Angeles, California, 90095
The West Clinic
Memphis, Tennessee, 38138
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Virtua Health Cancer Program
Mount Holly, New Jersey, 08060
Monroe Medical Associates
Munster, Indiana, 46321
Virginia Oncology Associates
Norfolk, Virginia, 23502
Oregon Health Sciences University
Portland, Oregon, 97239
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Bux-Mont Oncology Hematology Associates (FCCC) at Grand View Hospital
Sellersville, Pennsylvania, 18960
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601
Siteman Cancer Center
St Louis, Missouri, 63110
South Jersey Health Care
Vineland, New Jersey, 08360
Metro Health Cancer Care
Wyoming, Michigan, 49519
About this study
Official title: PARP Inhibition After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer or ER/PR +, HER2 Negative With Known BRCA1/2 Mutations: Hoosier Oncology Group BRE09-146
The purpose of this trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.
Read the detailed description
OUTLINE: This is a multi-center study.
Safety Run-in will be for the first 12 patients on study only (6 in cohort 1 and 6 in cohort 2). Patients in the safety run will be included in the efficacy analysis on intent to treat basis:
Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles; Rucaparib 16-30 mg IV D 1,2,3 every 3 weeks x 4 cycles
If cycle 1 is well tolerated, the dose of Rucaparib will be escalated from 16 mg to 24 mg for subsequent cycles in the cohort 1, and 24 mg to 30 mg in the cohort 2.
If ≤ 1 of 6 patients in cohort 1 experiences DLT, cohort 2 will commence. If 2 or more of 6 patients in cohort 1 experience DLT, the study will be suspended and an amendment to explore lower doses will be considered.
If ≤ 1 of 6 patients in cohort 2 experiences DLT, the randomized portion of the study will commence. If 2 or more of 6 patients experience DLT, the study will be suspended and an amendment to proceed with the randomized portion at the cohort 2 dose (24 mg) will be considered.
During the randomized portion of the study, patients will be randomized to either Arm A or Arm B.
Stratification factors:
- Anthracycline vs. not
- Residual LN involvement vs. No Residual LN involvement
Arm A (Cisplatin Monotherapy) Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles
Arm B (Combination Therapy) Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles; Rucaparib 16-30 mg IV D1,2,3 every 3 weeks x 4 cycles
Rucaparib maintenance 30 mg IV weekly x 24 weeks
ECOG Performance Status 0-1
Life Expectancy: Not Specified
Hematopoietic:
- Hemoglobin (Hgb) > 9.0 g/dL
- Platelets > 100 K/ mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
Hepatic:
- Bilirubin < upper limit of normal (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL)
- Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) < 2.5 x ULN
Renal:
- Calculated creatinine clearance of > 50 cc/min using the Cockcroft-Gault formula
Cardiovascular:
- Left ventricular ejection fraction within normal limits.
- Patients with an unstable angina or myocardial infarction within 12 months of study entry are excluded.
- No clinically significant arrhythmia or baseline ECG abnormalities in the opinion of the treating investigator.
- Conditions
- Breast Cancer
- Being tested
- Cisplatin, Rucaparib
- Keywords
- PARP inhibition + breast cancer, breast cancer, PARP inhibitor, Triple negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
RucaparibDrug
Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
CisplatinDrug
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Cisplatin Monotherapy | Active comparator | Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles Receives: Drug: Cisplatin |
| Arm B: Combination Therapy | Active comparator | Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles Receives: Drug: Rucaparib; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year Disease Free Survival
To evaluate 2-year disease-free survival (DFS), in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy
Measured: 24 months
Secondary outcomes (3)
Five-year Disease Free Survival
To evaluate 5-year DFS, in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy
Measured: 60 months
Overall Survival
To determine 5-year overall survival
Measured: 60 months
Summarize Grade 2,3, # 4 Toxicities
To characterize the side effects and tolerability of cisplatin and cisplatin plus Rucaparib in patients with residual disease following preoperative chemotherapy by summarizing Grade 2,3, # 4 toxicities according to CTCAE v3.0
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completion15 Dec 2018
- Study completion15 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Kathy D. Miller, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074970
- Sponsor's protocol ID
- BRE09-146
- Status last verified
- Sep 2024
- First submitted
- 23 Feb 2010
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
S. R. Malireddy, S. M. Perkins, S. S. Badve, G. W. Sledge, K. Miller. PARP inhibition after preoperative chemotherapy in patients with triple negative breast cancer (TNBC) or known BRCA1/2 mutations: Hoosier oncology group BRE09-146. J Clin Oncol 29: 2011 (suppl; abstr TPS130)
S. Dwadasi, Y. Tong, T. Walsh, M.A. Danso, C.X. Ma, P.A Silverman, M.C. King, S.M. Perkins, S.S. Badve, K. Miller. Cisplatin with or without rucaparib after preoperative chemotherapy in patients with triple negative breast cancer: Hoosier Oncology Group BRE09-146. J Clin Oncol 32:5s, 2014 (suppl; abstr 1019^)
Miller K, Tong Y, Jones DR, Walsh T, Danso MA, Ma CX, Silverman P, King MC, Badve SS, Perkins SM. Cisplatin with or without rucaparib after preoperative chemotherapy in patients with triple negative breast cancer: Final efficacy results of Hoosier Oncology Group BRE09-146. J Clin Oncol 33:5s, 2015 (suppl; abstr 1082)
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARP Inhibition After Preoperative Chemotherapy in Patients With Triple Negative Breast Cancer or ER/PR +, HER2 Negative With Known BRCA1/2 Mutations: Hoosier Oncology Group BRE09-146
- ClinicalTrials.gov ID
- NCT01074970
- Acronym / sponsor ID
- BRE09-146
- Conditions
- Breast Cancer
- Keywords
- PARP inhibition + breast cancer, breast cancer, PARP inhibitor, Triple negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Study start
- Feb 2010
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Dec 2018 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Posted 19 Sep 2024
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 trial is to evaluate 2-year disease-free survival in this patient population treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy. Side effects and tolerability of this treatment in patients with residual disease following preoperative chemotherapy will also be observed and characterized.
Detailed description
OUTLINE: This is a multi-center study.
Safety Run-in will be for the first 12 patients on study only (6 in cohort 1 and 6 in cohort 2). Patients in the safety run will be included in the efficacy analysis on intent to treat basis:
Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles; Rucaparib 16-30 mg IV D 1,2,3 every 3 weeks x 4 cycles
If cycle 1 is well tolerated, the dose of Rucaparib will be escalated from 16 mg to 24 mg for subsequent cycles in the cohort 1, and 24 mg to 30 mg in the cohort 2.
If ≤ 1 of 6 patients in cohort 1 experiences DLT, cohort 2 will commence. If 2 or more of 6 patients in cohort 1 experience DLT, the study will be suspended and an amendment to explore lower doses will be considered.
If ≤ 1 of 6 patients in cohort 2 experiences DLT, the randomized portion of the study will commence. If 2 or more of 6 patients experience DLT, the study will be suspended and an amendment to proceed with the randomized portion at the cohort 2 dose (24 mg) will be considered.
During the randomized portion of the study, patients will be randomized to either Arm A or Arm B.
Stratification factors:
- Anthracycline vs. not
- Residual LN involvement vs. No Residual LN involvement
Arm A (Cisplatin Monotherapy) Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles
Arm B (Combination Therapy) Cisplatin 75 mg/m2 IV D1 every 3 weeks x 4 cycles; Rucaparib 16-30 mg IV D1,2,3 every 3 weeks x 4 cycles
Rucaparib maintenance 30 mg IV weekly x 24 weeks
ECOG Performance Status 0-1
Life Expectancy: Not Specified
Hematopoietic:
- Hemoglobin (Hgb) > 9.0 g/dL
- Platelets > 100 K/ mm3
- Absolute neutrophil count (ANC) > 1.5 K/mm3
Hepatic:
- Bilirubin < upper limit of normal (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL)
- Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN
- Alanine aminotransferase (ALT, SGPT) < 2.5 x ULN
Renal:
- Calculated creatinine clearance of > 50 cc/min using the Cockcroft-Gault formula
Cardiovascular:
- Left ventricular ejection fraction within normal limits.
- Patients with an unstable angina or myocardial infarction within 12 months of study entry are excluded.
- No clinically significant arrhythmia or baseline ECG abnormalities in the opinion of the treating investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Cisplatin Monotherapy | Active comparator | Drug: CisplatinCisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles |
| Arm B: Combination Therapy | Active comparator | Drug: Rucaparib, Drug: CisplatinRucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer, stage I-III at diagnosis (AJCC 6th edition) based on initial evaluation by clinical examination and/or breast imaging. NOTE: Patients with ER+ and/or PR+ may enroll ONLY if they are known carriers of a deleterious mutation in BRCA1 or BRCA2. Patients with HER2+ tumors may not enroll regardless of BRCA status.
- Must have completed preoperative (neoadjuvant) chemotherapy. NOTE: Acceptable preoperative regimens include an anthracycline or a taxane, or both. Patients may NOT have received cisplatin as part of their neoadjuvant therapy regimen. Patients who received preoperative therapy as part of a clinical trial may enroll. No adjuvant chemotherapy after surgery other than that specified in this protocol is allowed. Adjuvant bisphosphonate use is allowed.
- Must have completed definitive resection of primary tumor. The last surgery for breast cancer must have been completed at least 14 days prior to registration for protocol therapy.
- Must have significant residual invasive disease at the time of definitive surgery following preoperative chemotherapy. Significant residual disease is defined at least one of the following:
- Whole breast radiotherapy is required for patients who underwent breast conserving therapy, including lumpectomy or partial mastectomy. Patients receiving adjuvant radiation therapy must have completed radiotherapy at least 14 days prior to registration for protocol therapy.
Key exclusion criteria (4 listed)
- No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease.
- No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- No history of chronic hepatitis B or C
- No clinically significant infections as judged by the treating investigator.
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 |
|---|---|---|
| CisplatinCisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles | Drug | Arm A: Cisplatin Monotherapy |
| RucaparibRucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles | Drug | Arm B: Combination Therapy |
| CisplatinCisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles | Drug | Arm B: Combination Therapy |
Primary outcome
Two-year Disease Free Survival
Time frame: 24 months
To evaluate 2-year disease-free survival (DFS), in patients with confirmed TNBC or ER/PR + HER2-, known BRCA1/2 mutations treated with single agent cisplatin and patients treated with cisplatin in combination with Rucaparib following preoperative chemotherapy
3 secondary outcomes
Five-year Disease Free Survival
Time frame: 60 months
Overall Survival
Time frame: 60 months
Summarize Grade 2,3, # 4 Toxicities
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundS. R. Malireddy, S. M. Perkins, S. S. Badve, G. W. Sledge, K. Miller. PARP inhibition after preoperative chemotherapy in patients with triple negative breast cancer (TNBC) or known BRCA1/2 mutations: Hoosier oncology group BRE09-146. J Clin Oncol 29: 2011 (suppl; abstr TPS130)
- BackgroundS. Dwadasi, Y. Tong, T. Walsh, M.A. Danso, C.X. Ma, P.A Silverman, M.C. King, S.M. Perkins, S.S. Badve, K. Miller. Cisplatin with or without rucaparib after preoperative chemotherapy in patients with triple negative breast cancer: Hoosier Oncology Group BRE09-146. J Clin Oncol 32:5s, 2014 (suppl; abstr 1019^)
- Results publicationMiller K, Tong Y, Jones DR, Walsh T, Danso MA, Ma CX, Silverman P, King MC, Badve SS, Perkins SM. Cisplatin with or without rucaparib after preoperative chemotherapy in patients with triple negative breast cancer: Final efficacy results of Hoosier Oncology Group BRE09-146. J Clin Oncol 33:5s, 2015 (suppl; abstr 1082)
- Hoosier Cancer Research Network HomepageLink provided by the sponsor.
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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.
Kathy D. Miller, M.D. study chair
Hoosier Cancer Research Network
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cisplatin and Rucaparib in people with Breast Cancer, run by Hoosier Cancer Research Network at 27 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 16 inclusion and 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Two-year Disease Free Survival (time frame: 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 NCT01074970, which also lists 3 linked publications.
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 19 Sep 2024.