Megestrol Acetate for Fatigue Management in T-DXd Treated Breast Cancer

NCT07543536 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: MEGA-TACT-BC3
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether the combination of Megestrol Acetate at the initiation of Trastuzumab Deruxtecan (T-DXd) treatment can effectively prevent and alleviate T-DXd-related fatigue, thereby improving the quality of life for advanced breast cancer patients.

Conditions

Advanced/Metastatic Breast Cancer; HER2+, Low, or Ultralow Advanced/Metastatic Breast Cancer

Keywords

Megestrol Acetate; Megestrol Acetate + Trastuzumab Deruxtecan

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Score (FACIT-Fatigue Scale)

  Measured by Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Scale Version 4. Total score range: 0-52, with higher scores indicating less fatigue and better quality of life.

  From baseline to end of 2nd cycle (approximately 6 weeks)

Secondary Outcomes (4)

• Change in Brief Fatigue Inventory (BFI) Score

  Time Frame：Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1).（each cycle is 28 days）

• Objective Response Rate (ORR)

  Assessed every 6 weeks up to 24 weeks

• Patient Reported Outcomes (PRO)

  Baseline (Day 1 of Cycle 1), Day 7 of Cycle 1, Cycle 2 (Day 1), Day 8 of Cycle 2, and Cycle 3 (Day 1)（each cycle is 28 days）

• Safety and Tolerability

  From first dose up to 30 days after last dose

Study Arms (2)

Experimental Group

EXPERIMENTAL

Megestrol Acetate + Trastuzumab Deruxtecan

Drug: Megestrol Acetate + Trastuzumab Deruxtecan

Control Group

PLACEBO COMPARATOR

Placebo + Trastuzumab Deruxtecan

Drug: Placebo + Trastuzumab Deruxtecan

Interventions

Megestrol Acetate + Trastuzumab Deruxtecan DRUG

Megestrol Acetate 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks

Experimental Group

Placebo + Trastuzumab Deruxtecan DRUG

Matched placebo 160mg orally, days 1-5, every 3 weeks for 2 cycles; Combined with standard Trastuzumab Deruxtecan 5.4 mg/kg IV infusion every 3 weeks

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 18-75 years
• Pathologically confirmed inoperable or metastatic breast cancer with complete ER, PR, and HER2 status
• HER2-positive (IHC 3+ or IHC 2+ with FISH positive), HER2-low (IHC 1+ or IHC 2+ with FISH negative), or HER2-ultralow (IHC 0 with ≤10% weak incomplete membrane staining) \[most recent specimen used\]
• Investigator-assessed indication for Trastuzumab Deruxtecan (T-DXd) therapy
• No prior treatment with Trastuzumab Deruxtecan
• Received ≤5 lines (including 5 lines) of prior chemotherapy
• ECOG Performance Status 0-1
• Estimated life expectancy ≥12 weeks
• Adequate organ function
• Reliable contraception or negative serum/urine pregnancy test within 7 days prior to enrollment; willing to use appropriate contraception during study and for 8 weeks after last dose
• Voluntary participation with good compliance

You may not qualify if:

• Severe underlying disease, comorbidities, active infection, or severe metabolic disorders
• Clinically significant severe fatigue at baseline (FACIT-F score \<30)
• Currently receiving other antitumor therapies
• Pregnant or lactating patients
• Poor compliance or unable to complete normal follow-up
• History of allergy to megestrol acetate or other components of the formulation
• History of thromboembolism (use with caution)
• Other malignancies diagnosed within 5 years, except: resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, locally radically treated prostate cancer, surgically radically treated ductal carcinoma in situ, or malignancies diagnosed \>2 years ago with no current disease evidence and untreated for ≤2 years before randomization
• Any condition judged by investigator that may affect study conduct or outcome assessment

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-Sen University Cancer Center

Guangzhou, Yuexiu District, 510060, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Megestrol Acetate; trastuzumab deruxtecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jiajia Huang, PhD / Doctorate

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meiting Chen Doctor, PhD / Doctorate

CONTACT

02087341812; chenmt@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Medical Oncology Professor, Principal Investigator, Chief Physician

Model Details: T-DXd: 5.4 mg/kg, IV drip, q3w. MA/Placebo: 160 mg, PO, d1-5, q3w for 2 cycles

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2031
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)