EUCTR2021-000603-21-PL进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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?
- •- ECOG performance status of 0 or 1 at randomization
- •- Adequate organ and bone marrow function
- •- LVEF = 50% within 28 days before randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 765
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •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
- •- 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
- •- 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
研究者
相似试验
招募中
3 期
A Phase 3 Trial of Neoadjuvant 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)HER2-positive early breast cancerJPRN-jRCT2041210097Inoguchi Akihiro900
进行中（未招募）
3 期
Global open label phase-III study having 3 treatment arm in neoadjuvant setting in Patients with High-risk HER 2-positive Early-stage Breast CancerCTRI/2022/01/039210ASTRAZENECA AB
招募中
3 期
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 mamaPER-067-21AstraZeneca AB22
进行中（未招募）
1 期
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: 100000004864EUCTR2021-000603-21-ITASTRAZENECA AB624
进行中（未招募）
1 期
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)EUCTR2021-000603-21-DEAstraZeneca AB900