Study Summary
This study is evaluating whether a drug used to treat breast cancer can be used to treat breast cancer in people with early stage breast cancer.
Eligible Conditions
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 27 Secondary · Reporting Duration: Median follow-up was 3.9 years. The AE data cutoff date is 21 April 2020.
2 years
Disease Free Survival in Patient Groups Defined by Tumor Size
Disease Free Survival in Patients Treated with T-DM1
Overall Survival in Patients Treated with T-DM1
Amenorrhea
Percentage of participants with Grade 3-4 Cardiac Dysfunction
Thrombocytopenia
3 years
Ado-trastuzumab emtansine
3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status
Year 5
Number of Participants of Clinically Relevant Toxicities (CRT)
Year 5
Incidence Rate of Grade 3-4 Treatment-Related Toxicity
Number of Incidence of Grade 3-4 Cardiac Left Ventricular Dysfunction
Number of Incidence of T-DM1 Induced Grade 2-3 Thrombocytopenia
After treatment
Gene Mutation Assessed Using High-throughput Mutation Profiling System (Oncomap)
Week 39
Number of SNPs With Top Associations of Trastuzumab Emtansine-induced Grade 2-4 Thrombocytopenia in the T-DM1 Arm
May 17, 2013, and December 13, 2016
Thrombocytopenia
Year 9
Number of Patients Have Alopecia
Year 5
Median Overall Survival (OS)
Month 18
Amenorrhea
Month 18
Percentage of Activity Impairment Because of Health
Percentage of Impairment While Working Because of Health (Mean, SD)
Percentage of Overall Work Impairment Because of Health
Percentage of Work Time Missed Because of Health
Month 18
Number of Patients Has Neuropathy
at 1 year
Quality of Life (QOL) FACT B Total Score at 1 Year
at 18 months
Quality of Life (QOL) FACT B Total Score at 18 Months
at 24 months
Quality of Life (QOL) FACT B Total Score at 24 Months
at 6 months
Quality of Life (QOL) FACT B Total Score at 6 Months
at baseline
Quality of Life (QOL) FACT B Total Score at Baseline
at week 12
Quality of Life (QOL) FACT B Total Score at Week 12
at week 3
Quality of Life (QOL) FACT B Total Score at Week 3
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
Trastuzumab emtansine (T-DM1)
1 of 4
Paclitaxel + Trastuzumab
1 of 4
Study Drug
1 of 4
Standard of Care
1 of 4
Active Control
512 Total Participants · 4 Treatment Groups
Primary Treatment: Trastuzumab emtansine (T-DM1) · No Placebo Group · Phase 2
Trastuzumab emtansine (T-DM1)
Drug
ActiveComparator Group · 1 Intervention: Trastuzumab emtansine · Intervention Types: DrugPaclitaxel + TrastuzumabActiveComparator Group · 2 Interventions: Trastuzumab, Paclitaxel · Intervention Types: Drug, Drug
Study Drug
Drug
ActiveComparator Group · 1 Intervention: Trastuzumab emtansine · Intervention Types: DrugStandard of CareActiveComparator Group · 2 Interventions: Trastuzumab, Paclitaxel · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: median follow-up was 3.9 years. the ae data cutoff date is 21 april 2020.
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,017 Previous Clinical Trials
393,316 Total Patients Enrolled
134 Trials studying Breast Cancer
21,156 Patients Enrolled for Breast Cancer
Sara Tolaney, MD, MPHPrincipal InvestigatorDana-Farber Cancer Institute
7 Previous Clinical Trials
600 Total Patients Enrolled
6 Trials studying Breast Cancer
566 Patients Enrolled for Breast Cancer
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. J Clin Oncol. 2021 Jul 20;39(21):2375-2385. doi: 10.1200/JCO.20.03398. Epub 2021 Jun 2.
- Barroso-Sousa R, Tarantino P, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy KJ, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I, Tolaney SM. Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. NPJ Breast Cancer. 2022 Feb 16;8(1):18. doi: 10.1038/s41523-022-00385-2.
- Sara Tolaney, MD 2013. "T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01853748.
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Conditions
Cancer Related
Treatments