Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer (DTP)
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|ClinicalTrials.gov Identifier: NCT03820141|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : April 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Durvalumab Drug: Trastuzumab Drug: Pertuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase II Trial of Durvalumab (MEDI4736) With Trastuzumab and Pertuzumab Combination in HER2-Enriched and HER2-Amplified Breast Cancer (DTP Trial)|
|Actual Study Start Date :||March 3, 2020|
|Estimated Primary Completion Date :||September 2024|
|Estimated Study Completion Date :||February 2025|
Experimental: Durvalumab + Trastuzumab + Pertuzumab
Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.
programmed cell death-ligand 1 inhibitor
Other Name: IMFINZI, MEDI4736
anti-HER2 monoclonal antibody
Other Name: Herceptin
anti-HER2 monoclonal antibody
Other Name: Perjeta
- Pathological complete response (pCR) rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer [ Time Frame: 18 weeks ]Determine pCR rate in the breast in patients with HER2-enriched and HER2-amplified breast cancer
- pCR rate in the breast in patients whose tumors have <5% and ≥5% tumor-infiltrating lymphocytes (TILs) [ Time Frame: 18 weeks ]Determine pCR rate in the breast in patients whose tumors have <5% and ≥5% TILs
- pCR rate in patients with programmed cell death-ligand 1 (PD-L1)-positive and PD-L1-negative tumors [ Time Frame: 18 weeks ]Determine pCR rate in the breast in patients with PD-L1-positive and PD-L1-negative tumors
- Three-year disease-free survival (DFS) rate in patients who achieve pCR [ Time Frame: 3 years ]Determination of 3-year DFS rate in patients who achieve pCR
- Number of participants with treatment-related adverse events [ Time Frame: 18 weeks ]Number of participants with treatment-related adverse events, as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Female aged >18 years at the time of study entry.
- Histologically confirmed HER2-enriched (by BluePrint) and HER2-amplified (ERBB2 mRNA >7.5-10) breast cancer.
- Estrogen receptor and progesterone receptor negative.
- Primary tumor greater than 1 cm diameter, measured by clinical examination and mammography or echography.
- Any nodal status
- Bilateral breast cancers that individually meet eligibility criteria are allowed.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Adequate organ and marrow function.
- Baseline left ventricular ejection fraction greater than or equal to 50%, as measured by multigated acquisition scan or echocardiogram.
- Evidence of postmenopausal status or negative serum pregnancy test for premenopausal patients. Negative serum beta-human chorionic gonadotropin pregnancy test within 7 days prior to the first dose of study treatment for premenopausal patients.
- Willing to provide biopsy tissues as required by the study.
- Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.
- Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Unresolved or unstable adverse events from prior administration of another investigational drug.
- Any concurrent chemotherapy, radiation therapy, immunotherapy, or biologic therapy for cancer treatment.
- Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.
- History of allogenic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- History of active primary immunodeficiency.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
- Patients who are pregnant or breastfeeding or patients of reproductive potential who are not willing to employ effective birth control from screening to 7 months after the last dose of study treatment.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820141
|Contact: Houston Methodist Cancer Centerfirstname.lastname@example.org|
|Contact: Jenny Chang, M.D.||email@example.com|
|United States, Texas|
|Houston Methodist Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jenny C Chang, MD 713-441-0629 firstname.lastname@example.org|
|Principal Investigator:||Jenny Chang, M.D.||Houston Methodist Cancer Center|
|Responsible Party:||Jenny C. Chang, MD, Director, Houston Methodist Cancer Center, The Methodist Hospital Research Institute|
|Other Study ID Numbers:||
|First Posted:||January 29, 2019 Key Record Dates|
|Last Update Posted:||April 10, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Site
Antineoplastic Agents, Immunological