A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
a study on Breast Cancer
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedcompletion around
Description
Summary
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.
Official Title
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Details
The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor low/HER2-negative breast cancer, by central assessment of pCR and/or to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer, by investigator assessment of EFS
Keywords
Breast Cancer, Breast Cancer;, Dato-DXd; DS1062a;, TROP2;, TNBC;, HR low:, Datopotamab deruxtecan;, Antibody Drug Conjugate;, ADC;, neoadjuvant therapy;, adjuvant therapy;, durvalumab;, PD-L1;, immune-checkpoint inhibitor (ICI);, Breast Neoplasms, Paclitaxel, Cyclophosphamide, Carboplatin, Doxorubicin, Pembrolizumab, Capecitabine, Durvalumab, Epirubicin, Olaparib, Dato-DXd, Dato-DXd plus durvalumab, Pembrolizumab plus chemotherapy
Eligibility
You can join if…
Open to people ages 18 years and up
- Participant must be ≥ 18 years, at the time of signing the ICF.
- Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
- ECOG PS of 0 or 1
- Provision of acceptable tumor sample
- Adequate bone marrow reserve and organ function
- Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
You CAN'T join if...
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence.
- Evidence of distant disease.
- Clinically significant corneal disease.
- Has active or uncontrolled hepatitis B or C virus infection.
- Known HIV infection that is not well controlled.
- Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
- Known to have active tuberculosis infection
- Resting ECG with clinically significant abnormal findings.
- Uncontrolled or significant cardiac disease.
- History of non-infectious ILD/pneumonitis
- Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
- For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
- Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
Locations
- Research Site
not yet accepting patients
Los Angeles California 90095 United States - Research Site
not yet accepting patients
Van Nuys California 91405 United States - Research Site
not yet accepting patients
Orange California 92868 United States - Research Site
not yet accepting patients
Los Angeles California 90033 United States - Research Site
accepting new patients
Santa Rosa California 92805 United States - Research Site
withdrawn
Sylmar California 91342 United States - Research Site
not yet accepting patients
Torrance California 90505 United States - Research Site
not yet accepting patients
Fullerton California 92835 United States - Research Site
accepting new patients
Tacoma Washington 98405 United States
Details
- Status
- accepting new patients at some sites,
but this study is not currently recruiting here - Start Date
- Completion Date
- (estimated)
- Sponsor
- AstraZeneca
- ID
- NCT06112379
- Phase
- Phase 3 Breast Cancer Research Study
- Study Type
- Interventional
- Participants
- Expecting 1728 study participants
- Last Updated