Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.

Part of paid clinical trials in Aurora, Colorado.

Sponsor
AstraZeneca
Study ID
NCT03616587
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • ER+ HER2- Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD9833 — DRUG
    Part A: AZD9833 monotherapy dose escalation.
  • AZD9833 — DRUG
    Part B: AZD9833 monotherapy expansion.
  • AZD9833 with palbociclib — DRUG
    Part C: AZD9833 in combination with palbociclib dose escalation
  • AZD9833 with palbociclib — DRUG
    Part D: AZD9833 in combination with palbociclib expansion
  • AZD9833 with everolimus — DRUG
    Part E: AZD9833 in combination with everolimus dose escalation
  • AZD9833 with everolimus — DRUG
    Part F: AZD9833 in combination with everolimus dose expansion
  • AZD9833 with abemaciclib — DRUG
    Part G: AZD9833 in combination with abemaciclib (± anastrozole) dose escalation
  • AZD9833 with abemaciclib — DRUG
    Part H: AZD9833 in combination with abemaciclib (± anastrozole) dose expansion
  • AZD9833 with capivasertib — DRUG
    Part I: AZD9833 in combination with capivasertib dose escalation
  • AZD9833 with capivasertib — DRUG
    Part J: AZD9833 in combination with capivasertib dose expansion
  • AZD9833 with ribociclib — DRUG
    Part K: AZD9833 in combination with ribociclib (± anastrozole) dose escalation
  • AZD9833 with ribociclib — DRUG
    Part L: AZD9833 in combination with ribociclib (± anastrozole) dose expansion
  • AZD9833 with anastrozole — DRUG
    Part M: AZD9833 in combination with anastrozole dose escalation
  • AZD9833 with anastrozole — DRUG
    Part N: AZD9833 in combination with anastrozole dose expansion

Study Details

A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)

Key Dates

Start date
Oct 11, 2018
Status verified
Apr 2026
Primary completion
Sep 16, 2024
Completion
Jun 24, 2027

Study Design

Enrollment
396 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD9833 monotherapy dose escalation
  • Experimental: AZD9833 monotherapy dose expansion
  • Experimental: AZD9833 with palbociclib dose escalation
  • Experimental: AZD9833 with palbociclib dose expansion
  • Experimental: AZD9833 with everolimus dose expansion
  • Experimental: AZD9833 with everolimus dose escalation
  • Experimental: AZD9833 with abemaciclib (± anastrozole) dose escalation
  • Experimental: AZD9833 with abemaciclib (± anastrozole)dose expansion
  • Experimental: AZD9833 with capivasertib dose escalation
  • Experimental: AZD9833 with capivasertib dose expansion
  • Experimental: AZD9833 with ribociclib (± anastrozole) dose escalation
  • Experimental: AZD9833 with ribociclib (± anastrozole) dose expansion
  • Experimental: AZD9833 with anastrozole dose escalation
  • Experimental: AZD9833 with anastrozole dose expansion

Primary Outcome Measure

The number of subjects with dose-limiting toxicity, as defined in the protocol. [ Time Frame: Minimum observation period 28 days on treatment. ]

Locations (5)

FacilityCityStateZIPSite coordinators
Research SiteAuroraColorado80045-
Research SiteSarasotaFlorida34232-
Research SitePhiladelphiaPennsylvania19111-
Research SiteNashvilleTennessee37203-
Research SiteSalt Lake CityUtah84112-

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Research Site· Aurora, COResearch Site· Sarasota, FLResearch Site· Philadelphia, PAResearch Site· Nashville, TNResearch Site· Salt Lake City, UT

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