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Not recruiting
Phase 3

Camizestrant

Sponsor:

AstraZeneca

Code:

NCT05952557

Conditions

Breast Cancer, Early Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Camizestrant

Tamoxifen

Anastrozole

Letrozole

Exemestane

Study Details

Brief summary:

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm within the study will be 7 years.

Conditions

Breast Cancer, Early Breast Cancer

Study ID

NCT05952557

Start date

Oct 5, 2023

Status verified date

Aug, 2026

Completion date

May 6, 2037

Anticipated

Primary completion date

Mar 4, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women and Men; ≥18 years at the time of screening (or per national guidelines)
  • Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with absence of any evidence of metastatic disease as defined in the protocol.
  • Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy.
  • Patients must be randomised within 12 months of definitive breast surgery.
  • Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Adequate organ and bone marrow function

Exclusion Criteria:

  • Inoperable locally advanced or metastatic breast cancer
  • Pathological complete response following treatment with neoadjuvant therapy
  • History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or considered a very low risk of recurrence per investigator judgement) unless in complete remission with no therapy for a minimum of 5 years from the date of randomisation
  • Any evidence of severe or uncontrolled systemic diseases which, in the investigator's opinion precludes participation in the study or compliance "
  • Known LVEF <50% with heart failure NYHA Grade ≥2.
  • Mean resting QTcF interval > 480 ms at screening
  • Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy for non-cancer-related conditions
  • Any concurrent anti-cancer treatment not specified in the protocol with the exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg, denosumab)
  • Previous treatment with camizestrant, investigational SERDs/investigational ER targeting agents, or fulvestrant
  • Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.
  • Patients with known hypersensitivity to active or inactive excipients of camizestrant or drugs with a similar chemical structure or class to camizestrant. In pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance to LHRH agonists that would preclude the patient from receiving any LHRH agonist.

Study Design

Enrollment

5511 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib

standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib

experimental: Arm B: camizestrant ± abemaciclib

camizestrant ± abemaciclib

Interventions

Camizestrant

Camizestrant. Experimental. Administered orally

Tamoxifen

Tamoxifen. Comparator. Administered orally

Anastrozole

Anastrozole. Comparator. Administered orally

Letrozole

Letrozole. Comparator. Administered orally

Exemestane

Exemestane. Comparator. Administered orally

Abemaciclib

Abemaciclib adjuvant treatment Administered orally

Primary outcome measure

  • Invasive breast cancer-free survival (IBCFS) [ Time Frame: Up to 14 years ]

Central Contacts and Locations

More Information

Sponsor

AstraZeneca

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • ER+
  • HER2-
  • breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-20. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-10.