Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva) (POP-DURVA)
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ClinicalTrials.gov Identifier: NCT05215106 |
Recruitment Status :
Recruiting
First Posted : January 31, 2022
Last Update Posted : June 6, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | December 22, 2021 | ||||||||
First Posted Date ICMJE | January 31, 2022 | ||||||||
Last Update Posted Date | June 6, 2023 | ||||||||
Actual Study Start Date ICMJE | December 6, 2021 | ||||||||
Estimated Primary Completion Date | June 2026 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
pCR rate after 2 administrations of durvalumab [ Time Frame: Assessed at Day 29 (for patients performing surgery) or at Day 22 (for patients starting neoadjuvant systemic treatment) ] Defined as the absence of invasive disease in the breast and negative axillary nodes (ypT0/yTis ypN0)
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Original Primary Outcome Measures ICMJE |
pCR rate after 6 weeks of durvalumab [ Time Frame: Assessed during surgery at Day 42 ] Defined as the absence of invasive disease in the breast and negative axillary nodes (ypT0/yTis ypN0)
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva) | ||||||||
Official Title ICMJE | Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva) | ||||||||
Brief Summary | This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients with early small (cT1N0) triple negative breast cancer tumors. This study will recruit patients with early HR-negative breast cancer all invasive types (ER < 1%, PR < 1%, HER2 negative) and TILs >=5%, eligible for a short-term treatment with Durvalumab. A total of 200 patients are planned to be enrolled in the study and which will receive 2 administrations of durvalumab 10mg/kg. After study treatment, patients:
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Early Small (cT1N0) Triple Negative Breast Cancer | ||||||||
Intervention ICMJE | Drug: Durvalumab
Following preparation of durvalumab, the entire contents of the IV bag should be administered as an IV infusion over approximately 60 minutes (±5 minutes), using a 0.2μm in-line filter (or add-on filter).
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Study Arms ICMJE | Experimental: Durvalumab
All patients enrolled in the study will receive 2 administrations of durvalumab 10mg/kg monotherapy before any standard treatment.
Intervention: Drug: Durvalumab
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
200 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2026 | ||||||||
Estimated Primary Completion Date | June 2026 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Note: A highly effective birth control method is a one, which can achieve a failure rate of less than 1% per year when used consistently and correctly. Such methods include: combined (estrogen and progestogen containing) hormonal contraception; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence during the entire period of risk associated with study treatment. To prevent the risk of interaction between the study drug and hormonal contraceptives, hormonal contraceptives should be supplemented with a barrier method (preferably male condom). Following methods are considered as unacceptable methods (non-exhaustive list): periodic abstinence (calendar, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus). - Blood tests demonstrating: Creatinine ≤ 1.5 x ULN Bilirubin ≤ 1.5 x ULN, AST or ALT < 3 x ULN, ALP < 2.5 x ULN (patients with known Gilbert disease who have serum bilirubin level ≤ 3 × the institutional ULN may be enrolled) For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN. For patients receiving therapeutic anticoagulation: stable anticoagulant regimen Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb > 9 g/dL, Serum albumin > 2.5 g/dL Fasting Serum amylase ≤ 2 × ULN Fasting Serum lipase ≤ ULN - Patients must be affiliated to a social security system or beneficiary of the same. Exclusion Criteria:
Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued or replaced by safe alternative medication Bradycardia (heart rate < 50 at rest), by ECG or pulse.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05215106 | ||||||||
Other Study ID Numbers ICMJE | 2020-006106-23 2020/3210 ( Other Identifier: CSET number ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Gustave Roussy, Cancer Campus, Grand Paris | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Gustave Roussy, Cancer Campus, Grand Paris | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | AstraZeneca | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Gustave Roussy, Cancer Campus, Grand Paris | ||||||||
Verification Date | June 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |