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Clinical Trials/EUCTR2021-000603-21-DE
EUCTR2021-000603-21-DE
Active, not recruiting
Phase 1

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11) - DESTINY-Breast11

AstraZeneca AB0 sites900 target enrollmentMay 18, 2022
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ConditionsEarly stage HER2-positive breast cancer (T stage >= T3, lymph node positive, or inflammatory)MedDRA version: 21.0Level: LLTClassification code 10025541Term: Malignant breast neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsBentadaxperjetaHerzumaDoxorubicin Teva 2mg/ml Concentration for solution for infusionEndoxan

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Early stage HER2-positive breast cancer (T stage >= T3, lymph node positive, or inflammatory)
Sponsor
AstraZeneca AB
Enrollment
900
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 18, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Key Inclusion Criteria:
  • •\- Patients must be at least 18 years of age.
  • •\- Histologically documented HER2\-positive EBC participants with:
  • •(a) Locally assessed HER2\-positive (IHC 3\+ or ISH\+) according to ASCO\-CAP guidelines and prospectively centrally confirmed as HER2 positive based on a tumour sample
  • •(b) Unifocal and multifocal tumours (\> 1 tumour confined to the same quadrant as the primary tumour) must have 1 focus sampled and centrally confirmed as HER2 positive
  • •(c) Multi\-centric tumours (multiple tumours involving \> 1 quadrant of the breast) must have 1 lesion from each involved quadrant sampled and centrally confirmed as HER2 positive. All quadrants tested must be centrally confirmed as HER2 positive
  • •(d) Tumours documented as HR\-positive (either ER and/or PgR positive \[ER or PgR \= 1%]) or HR\-negative (ER and PgR negative) by local assessment per ASCO\-CAP guidelines (Allison et al 2020\)
  • •(e) Clinical stage at presentation (based on mammogram or breast MRI assessment): T0\-4 (inclusive of inflammatory breast cancer), N1\-3, M0 or \= T3, N0, M0 as determined by the AJCC staging system, 8th edition (Hortobagyi et al 2017\)
  • •(f) Pathologic confirmation of nodal involvement with malignancy as determined by fine\-needle aspiration or core\-needle biopsy, when applicable.
  • •\- FFPE tissue block (2 cores) or 20 freshly\-cut, serial tumor slides for HER2 assessment by central lab. If blocks are incomplete or fewer than 20 slides are available, participants may be eligible following discussion with the AstraZeneca Study Physician?

Exclusion Criteria

  • •Key Exclusion Criteria:
  • •\- Prior history of invasive breast cancer
  • •\- Any primary malignancy within 3 years, except adequately resected non\-melanoma skin cancer, or curatively treated in situ disease)
  • •Note: This includes a second current breast primary malignancy (ie, bilateral breast cancer
  • •\- History of DCIS, except for participants treated with mastectomy only \> 5 years prior to current diagnosis
  • •\- Prior sentinel lymph node biopsy or axillary lymph node dissection before initiation of neoadjuvant treatment
  • •\- Prior systemic therapy for the treatment of breast cancer
  • •\- Previous treatment with anthracyclines, cyclophosphamide or taxanes for any malignancy; cyclophosphamide allowed for non\-cancer treatment if last dose \> 6 months
  • •\- Ineligible for any medication in the control Arm C
  • •\- Any concurrent anticancer treatment

Outcomes

Primary Outcomes

Not specified

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A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11)C50 Cancer de mama
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DESTINY-Breast11 will compare trastuzumab deruxtecan (T-DXd) alone or in sequence with other medications, known as THP, with standard of care treatment (ddAC-THP) and determine its safety and efficacy in patients with HER2-positive early breast cancer.Early stage HER2-positive breast cancer (T stage >= T3, lymph node positive, or inflammatory)MedDRA version: 21.0Level: LLTClassification code 10025541Term: Malignant breast neoplasmSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
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DESTINY-Breast11 will compare trastuzumab deruxtecan (T-DXd) alone or in sequence with other medications, known as THP, with standard of care treatment (ddAC-THP) and determine its safety and efficacy in patients with HER2-positive early breast cancer.Early stage HER2-positive breast cancer (T stage >= T3, lymph node positive, or inflammatory)MedDRA version: 21.0Level: LLTClassification code 10025541Term: Malignant breast neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2021-000603-21-PLAstraZeneca AB900