Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer

Conditions

• Early-stage Breast Cancer
• Hormone Receptor Positive Breast Carcinoma
• Invasive Breast Cancer
• Stage II Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage III Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Anastrozole — DRUG
  Given PO
• Therapeutic Conventional Surgery — PROCEDURE
  Undergo surgery
• Trastuzumab Deruxtecan — BIOLOGICAL
  Given IV

Study Details

This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer. Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 expressed at low levels on cancer cells in a targeted way and delivers deruxtecan to kill them. Anastrozole works by decreasing estrogen production and suppressing the growth of tumors that need estrogen to grow. This study is evaluating how effective trastuzumab deruxtecan is at treating hormone receptor positive cancer cells that have low levels of HER2 expressed on them when given alone or in combination with anastrozole.

Key Dates

Start date

Oct 9, 2020

Status verified

Nov 2025

Primary completion

Dec 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

88 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm A (trastuzumab deruxtecan)
  Patients receive trastuzumab deruxtecan IV over 90 minutes on cycle 1 day 1 and 30 minutes on day 1 of each subsequent cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
• Experimental: Arm B (trastuzumab deruxtecan, anastrozole)
  Patients receive trastuzumab deruxtecan IV over 90 minutes on cycle 1 day 1 and 30 minutes on day 1 of each subsequent cycle and anastrozole PO QD on days 1-21. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Primary Outcome Measure

Pathologic complete response (pCR) rate [ Time Frame: Baseline to surgery ]

Central Contacts

• TRIO-US
  310-829-5471
  [email protected]

Locations (9)

Find similar trials in Fullerton, CA

Related Studies

• I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
  PHASE2 · Recruiting · QuantumLeap Healthcare Collaborative · Birmingham, Alabama
• Sacituzumab Govitecan In TNBC
  PHASE2 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts
• Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
  PHASE2 · Recruiting · City of Hope Medical Center · Duarte, California
• SABER Study for Selected Early Stage Breast Cancer
  Recruiting · University of Miami · Miami, Florida