A Phase II Evaluation of Afatinib in Patients With Persistent or Recurrent HER2-positive Uterine Serous Carcinoma

Conditions

• HER2/Neu+ Uterine Serous Carcinoma

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Afatinib — DRUG
  Afatinib, 40 mg orally once daily on a 21 day cycle for the first 12 weeks, then every 28 days for subsequent cycles until progression

Study Details

Primary Objective: To assess the activity of Afatinib in patients with persistent or recurrent uterine serous carcinoma overexpressing HER2/neu with the frequency of patients who survive progression-free for at least 6 months after initiating therapy. Secondary Objectives: To assess objective response rate and durable disease control rate. To assess overall survival. To assess the safety profile of Afatinib in uterine serous carcinoma patients.

Key Dates

Start date

Jun 30, 2015

Status verified

Oct 2025

Primary completion

Jul 31, 2026

Completion

Jul 31, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Afatinib
  Afatinib 40 mgs., Q 21 Day times 4 Cycles

Primary Outcome Measure

Progression free survival [ Time Frame: 4 Years ]

Central Contacts

• Alessandro D. Santin, M.D.
  203-737-4450
  [email protected]
• Lisa Baker, R.N.
  203-785-6398
  [email protected]

Locations (3)

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