A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol. (ADAPT; T-DM1)
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|ClinicalTrials.gov Identifier: NCT01745965|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2012
Last Update Posted : July 23, 2019
Trial to optimize neoadjuvant therapy for HER overexpression and co-expressing of hormone receptors(ER and/or PR) breast cancer (HEr2+/HR+).
A new high potential trastuzumab conjugate T-DM1(trastuzumab was linked with the cytotoxic agent mertansine DM1)was tested with endocrine therapy and without against a standard arm with trastuzumab and endocrine therapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: T-DM1 Drug: Trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||380 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||October 2020|
single agent T-DM1 for 12 weeks (3,6 mg/kg q3w)
Experimental: T-DM1 + endocrine therapy
Single agent T-DM1 for 12 weeks (3,6 mg/kg q3w) with standard endocrine therapy (tamoxifen in premenopausal women and an aromatase inhibitor in postmenopausal women, if no contraindications are present, in a standard daily dosage).
Active Comparator: Trastuzumab + endocrine therapy
The control group will receive trastuzumab in 3-weekly schedule (8 mg/kg as loading dose and then 6 mg/kg q3w)with endocrine therapy tamoxifen in premenopausal women and an aromatase inhibitor in postmenopausal women, if not contraindications are present, in a standard daily dosage).
Other Name: Herceptin
- Comparison of the pCR rates in patients with HER2+/HR+ breast cancer treated by preoperative T-DM1 with or without standard endocrine therapy or trastuzumab with endocrine therapy. [ Time Frame: After 12 weeks ]pCR will be measured after 12 weeks of randomized treatment.
- Evaluation of dynamic testing (based on proliferation/apoptosis changes in serial biopsy and imaging by MRI) after three weeks of treatment as a surrogate parameter for response. [ Time Frame: after 3 weeks of treamtment ]Response: pCR (residual cancer burden (RCB) 0-1) or resistance/low response (RCB II-III or progressive disease)
- Evaluation of dynamic test regarding prediction of 5-year event-free survival (EFS) [ Time Frame: 5 year after treatment ]
- Overall survival [ Time Frame: 5 year after treamtment ]
- Toxicity/cardiac safety [ Time Frame: 5 years after treatment ]
- Overall safety in the three treatment arms [ Time Frame: 5 years after treatment ]
- Health-related quality of life (HRQL) [ Time Frame: After 5 year after treatment of last patient ]
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): NCT01745965
|Breast Center of the University of Munich (LMU)|
|Ev. Krankenhaus Bethesda Brustzentrum Niederrhien|
|Principal Investigator:||Nadia Harbeck, Prof. Dr.||Breast Center of the University of Munich (LMU), Universitätsfrauenklinik Großhadern, Munich, Germany|
|Study Chair:||Ulrike Nitz, Prof. Dr.||Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany|