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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.
EU CTIS ID: 2023-505210-18-00
What this study is testing
"This is a Phase 3, open-label, three-arm study to determine the safety and efficacy of T-DXd monotherapy or T-DXd followed by THP as neoadjuvant treatment compared to standard of care (ddAC-THP) in participants with locally advanced or inflammatory HER2-positive early breast cancer. The target population of interest in this study is participants with high-risk HER2-positive early breast cancer. Participants will be randomized in a 1:1:1 ratio to one of the following intervention groups: T DXd monotherapy (Arm A), T-DXd followed by THP (Arm B), or ddAC-THP (Arm C). The primary objective is to demonstrate the superiority of neoadjuvant T-DXd alone or in sequence with THP relative to ddAC-THP by assessment of pCR (pathological complete response, ypT0/Tis ypN0) using central evaluation in participants with HER2-positive early breast cancer."
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- ECOG performance status of 0 or 1 at randomization
- Adequate organ and bone marrow function
- LVEF ≥ 50% within 28 days before randomization
You likely can't join if
- Prior history of invasive breast cancer
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any pulmonary disorder
- Investigator judgement of 1 or more of the following: (a) Mean resting corrected QTcF interval of >470 ms (females) or >450 ms (males) (b) History of QT prolongation associated with other medications that required discontinuation of that medication or any medication known to prolong QT interval and cause TdP. (c) Congenital long QT syndrome, family history of long QT syndrome or unexplained death under 40 years in first degree relatives
- History of arrhythmia, symptomatic or uncontrolled atrial fibrillation or asymptomatic sustained ventricular tachycardia
- 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
See the full eligibility 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
- ECOG performance status of 0 or 1 at randomization
- Adequate organ and bone marrow function
- LVEF ≥ 50% within 28 days before randomization
- Prior history of invasive breast cancer
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any pulmonary disorder
- Investigator judgement of 1 or more of the following: (a) Mean resting corrected QTcF interval of >470 ms (females) or >450 ms (males) (b) History of QT prolongation associated with other medications that required discontinuation of that medication or any medication known to prolong QT interval and cause TdP. (c) Congenital long QT syndrome, family history of long QT syndrome or unexplained death under 40 years in first degree relatives
- History of arrhythmia, symptomatic or uncontrolled atrial fibrillation or asymptomatic sustained ventricular tachycardia
- 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
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
The study team makes the final eligibility decision.
Where it's taking place
- Philippines
- Japan
- India
- Canada
- Korea, Republic of
- Russian Federation
- United States
- Brazil
- Thailand
- Saudi Arabia
- Peru
- Taiwan
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philippines; Japan; India; Canada; Korea, Republic of; Russian Federation and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.