ATEMPT 2.0: Adjuvant T-DM1 vs TH

Conditions

• Breast Cancer
• HER2-positive Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• trastuzumab-emtansine — DRUG
  intravenous infusion
• Trastuzumab SC — DRUG
  Muscular injection
• Paclitaxel — DRUG
  intravenous infusion

Study Details

This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM1, Kadcyla) * Trastuzumab SC (Herceptin Hylecta) * Paclitaxel

Key Dates

Start date

Jun 16, 2021

Status verified

Apr 2026

Primary completion

Nov 1, 2026

Completion

May 1, 2028

Study Design

Enrollment

500 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A. T-DM1 followed by Trastuzumab SC
  Randomized participants will receive intravenous T-DM1 every 3 weeks for 6 cycles (18 weeks) and then Trastuzumab SC (subcutaneous) every 3 weeks for 11 cycles
• Experimental: Arm B: Paclitaxel with Trastuzumab SC, followed by Trastuzumab SC alone
  Randomized participants will receive weekly intravenous Paclitaxel for 12 weeks (4 cycles) and Trastuzumab SC (subcutaneous) every 3 weeks for 17 cycles. The first 4 doses Trastuzumab SC are given with Paclitaxel.

Primary Outcome Measure

Incidence of clinically relevant toxicities (CRT) [ Time Frame: First 18 weeks of treatment ]

Central Contacts

• Sara Tolaney, MD, PhD
  617-632-2335
  [email protected]

Locations (53)

Find similar trials in San Francisco, CA

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