A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer

Part of paid clinical trials in Hot Springs, Arkansas.

Sponsor
TerSera Therapeutics LLC
Study ID
NCT07310420
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • ZOLADEX — DRUG
    Participants will receive ZOLADEX as a subcutaneous (SC) injection on Day 1 (Week 1), and Day 85 (Week 12) for a total of 2 treatments.

Study Details

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Mar 30, 2027

Study Design

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

Arms

  • Experimental: ZOLADEX 10.8 mg
    Participants will receive 10.8 mg ZOLADEX on Day 1 and Day 85.

Primary Outcome Measure

Percentage of Participants with LH Values Below a Specified Threshold at Week 6 [ Time Frame: Week 6 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Genesis Cancer and Blood InstituteHot SpringsArkansas71913
Stephen Divers, MD
MedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital CenterWashington D.C.District of Columbia20010
Ami Chitalia, MD
Cancer Centers of FloridaOcoeeFlorida34761
Gopal Kunta, MD
Summit Cancer CareSavannahGeorgia31405
Mark Taylor, MD
Duly Health and CareLisleIllinois60532
Daniel Frank, MD
Orchard Healthcare ResearchSkokieIllinois60077
Ira Oliff, MD
Profound Research LLC at Michigan Hematology and Oncology ConsultantsRoyal OakMichigan48073
Savitha Balaraman, MD
San Juan Oncology AssociatesFarmingtonNew Mexico87401
Jeffrey Neidhart, MD
The Mark H. Zangmeister Center-Mid Ohio Oncology/Hematology, Inc.ColumbusOhio43219
Jeanna Knoble, MD
Guthrie Medical GroupSayrePennsylvania18840
Joyson Poulose, MD
Oncology Consultants PAHoustonTexas77030
Ricardo Alvarez, MD

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By research site
Genesis Cancer and Blood Institute· Hot Springs, ARMedStar Heart & Vascular Institute (MHVI) - MedStar Washington Hospital Center· Washington D.C., DCCancer Centers of Florida· Ocoee, FLSummit Cancer Care· Savannah, GADuly Health and Care· Lisle, ILOrchard Healthcare Research· Skokie, IL

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