Ph 2 Elacestrant in ER Positive Uterine Sarcomas

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07467772
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • ESS
  • Endometrial Stromal Sarcoma
  • Estrogen Receptor Positive Tumor
  • Perivascular Epithelioid Cell Tumors
  • Uterine Adenosarcoma
  • Uterine Leiomyosarcoma
  • Uterine PEComa
  • Uterine Sarcoma
  • uLMS

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Elacestrant — DRUG
    Selective estrogen receptor degrader, tablet taken orally per protocol.

Study Details

This study is to evaluate the efficacy and safety of elacestrant, in participants with advanced estrogen receptor (ER)-positive uterine sarcomas. The name of the study drug involved in this research study is: -Elacestrant (a type of selective estrogen receptor degrader)

Key Dates

Start date
Mar 25, 2026
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Elacestrant
    30 participants will be enrolled and will complete the following: * Baseline visit * Cycle 1 through End of Treatment (28 day cycles) --Days 1 - 28: predetermined dose of Elacestrant 1x daily * End of treatment visit * 30 day post-treatment follow up * Long term follow every 3 months

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Observed on treatment plus 30 days; Disease assessed on treatment every 8 (+/- 3 days) weeks for the first 14 cycles, then every 12 (+/- 3 days) weeks thereafter with longest follow-up estimated as 12 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Suzanne George, MD
877-338-7425

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MA

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