Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer

Conditions

• Advanced Breast Cancer
• Breast Cancer
• Metastatic Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab deruxtecan — DRUG
  Standard of care trastuzumab deruxtecan is administered at a starting dose of 5.4 mg/kg intravenously every 3 weeks according to package guidelines. The first infusion is administered over 90 minutes, and subsequent infusions may be administered over 30 minutes if prior infusions were well tolerated.
• Lovastatin — DRUG
  Lovastatin is provided in 10 mg and 20mg tablets for oral administration. It will be taken approximately 12 hours and 10 minutes before each T-DXd cycle.

Study Details

The purpose of this study is to evaluate use of lovastatin, a drug that may lower CAV-1 levels, in order to increase HER2 expression on cells and enhance the uptake and efficacy of trastuzumab deruxtecan (T-DXd) in HER2-low and ultralow advanced metastatic breast cancer. Trastuzumab deruxtecan (T-DXd) is an FDA approved antibody drug conjugate for HER2-low and ultralow breast cancer and lovastatin is a cholesterol lowering agent.

Key Dates

Start date

Aug 31, 2026

Status verified

May 2026

Primary completion

Aug 31, 2030

Completion

Aug 31, 2031

Study Design

Enrollment

60 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Safety Lead In: Trastuzumab Deruxtecan (T-DXd) + Lovastatin
  T-DXd will be administered at a standard dose intravenously (IV) every 3 weeks and lovastatin will be administered orally at 20 mg with doses approximately 12 hours and 30 minutes before each cycle of T-DXd. Patients will be assessed for unacceptable toxicities during the first two treatment cycles.10 patients enrolled in either the safety lead-in or enrolled after the safety lead-in is completed will undergo a pre- and on-treatment biopsy for pharmacodynamic assessment.
• Experimental: Standard dose: T-DXd + Lovastatin
  T-DXd will be administered at a standard dose intravenously (IV) every 3 weeks and lovastatin will be administered orally at 20 mg with doses approximately 12 hours and 30 minutes before each cycle of T-DXd. 10 patients enrolled in either the safety lead-in or enrolled after the safety lead-in is completed will undergo a pre- and on-treatment biopsy for pharmacodynamic assessment.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Start of treatment through end of treatment (estimated total time 12 months) ]

Central Contacts

• Andrew A Davis, MD
  314-362-5740
  [email protected]

Locations (1)

Find similar trials in St Louis, MO

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