Evaluating 6-months of HER2-targeted Therapy in Patients With HER2 Positive Early-stage Breast Cancer That Achieve a Pathological Complete Response to Neoadjuvant Systemic Therapy

NCT04928261 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: REaCT-HER TIME
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The activity of trastuzumab in early-stage, HER2-positive breast cancer, has been demonstrated in many studies, with meta-analyses showing that in combination with a variety of chemotherapy backbones, trastuzumab reduces the risk of recurrence by nearly half, and death by a third. However, treatment with trastuzumab can result in cardiotoxicity, including heart failure, as well as the significant cost of treatment and the requirement for patients to attend the chemotherapy unit for treatment every 3 weeks for one year. Therefore there has been increasing interest in identifying which patients can safely have less treatment. The investigators therefore propose a real-world, single arm, multicentre trial evaluating 6 months of HER2 targeted therapy, for patients with early-stage, HER2 positive breast cancer, who achieve a pathological complete response (pCR) with upfront systemic chemotherapy and HER2 targeted therapy.

Conditions

Breast Cancer

Keywords

Cardiac toxicities; Her2 Positive; Pathological complete response

Outcome Measures

Primary Outcomes (3)

• Multiple site activation

  Evaluating the feasibility of multiple Canadian site activation within the first year of study accrual. Achieved by the activation of at least 4 Canadian sites within 1 year of the first patient being accrued into the study.

  1 year after first participant is accrued

• Medical oncologist active participation

  Evaluating the number of medical oncologists at each study site who actively participate in the trial. Active participation includes approaching eligible patients for the study, as well as following up with the patients who are taking part in the study.

  Through to end of accrual - average 2 years

• Enrolment of at least 50 participants across all sites within 9 months of the fourth site accruing its first participant

  Enrolment of at least 50 participants across all sites within 9 months of the fourth site accruing its first participant.

  9 months after fourth site accrues first participant

Secondary Outcomes (6)

• Cardiac events

  3 years after study enrolment

• Rate of HER2-positive treatment discontinuation

  6 months after study enrolment

• Health-related quality of life

  Baseline, 3, 6, 12 and 36 months after study enrolment

• Incremental cost-effectiveness ratios

  3 years from study enrolment

• Disease free survival

  3 years from study enrolment

Study Arms (1)

De-escalated HER2 targeted treatment

EXPERIMENTAL

Patients with early-stage HER2-positive breast cancer who demonstrate a pathological complete response at time of surgery.

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

Patients with early-stage HER2-positive breast cancer who demonstrate a pathological complete response at time of surgery will be treated with HER2 targeted therapy for a total of 9 treatments every 3 weeks (or its equivalent if given weekly) including the treatment received preoperatively.

Also known as: Herceptin

De-escalated HER2 targeted treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Early-stage (I-III, i.e. non-metastatic) as per AJCC 8th edition, ER/PR positive or negative, HER2-positive as per 2018 American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines.
• Treated with neoadjuvant chemotherapy and HER2 targeted therapy preoperatively with a pathological complete response (pCR) defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy at surgery. Must have received less than 6 months of HER2 targeted therapy
• Able to provide verbal consent and complete questionnaires in English or French

You may not qualify if:

• Residual invasive disease following neoadjuvant therapy, or metastatic disease
• Contraindication to further HER2-targeted therapy following completion of neoadjuvant treatment
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H8M2, Canada

Location

Related Publications (1)

• Bradbury M, Savard MF, Vandermeer L, Clemons L, Pond G, Hilton J, Clemons M, McGee S. Shorter Durations of Anti-HER2 Therapy for Patients with Early-Stage, HER2-Positive Breast Cancer: The Physician Perspective. Curr Oncol. 2023 Dec 14;30(12):10477-10487. doi: 10.3390/curroncol30120763.

  PMID: 38132397 BACKGROUND

Related Links

• The Rethinking Clinical Trials (REaCT) website

MeSH Terms

Conditions

Breast Neoplasms; Cardiotoxicity

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sharon McGee, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: June 16, 2021
• Study Start: December 13, 2021
• Primary Completion: December 15, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

CA (1)