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Clinical Trials in India / NCT05952557
Active, not recruiting Phase 3

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

NCT05952557 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2023-10-05
Last updated
2026-08-10

Condition(s) studied

Breast Cancer, Early Breast Cancer

Investigational drug(s) / intervention(s)

CamizestrantTamoxifenAnastrozoleLetrozoleExemestaneAbemaciclib

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (661)

FacilityCityRegionStatus
Research Site Dothan Alabama
Research Site Phoenix Arizona
Research Site Tucson Arizona
Research Site Fayetteville Arkansas
Research Site Duarte California
Research Site Fountain Valley California
Research Site Irvine California
Research Site La Jolla California
Research Site Los Angeles California
Research Site Walnut Creek California
Research Site West Hollywood California
Research Site Aurora Colorado
Research Site Littleton Colorado
Research Site Littleton Colorado
Research Site New Haven Connecticut
Research Site Newark Delaware
Research Site Clearwater Florida
Research Site Fort Myers Florida
Research Site Gainesville Florida
Research Site Jacksonville Florida
Research Site Pembroke Pines Florida
Research Site Plantation Florida
Research Site Plantation Florida
Research Site St. Petersburg Florida
Research Site St. Petersburg Florida
Research Site Tallahassee Florida
Research Site West Palm Beach Florida
Research Site Atlanta Georgia
Research Site Marietta Georgia
Research Site Thomasville Georgia
Research Site Chicago Illinois
Research Site Elmhurst Illinois
Research Site Naperville Illinois
Research Site Urbana Illinois
Research Site Fort Wayne Indiana
Research Site Des Moines Iowa
Research Site Louisville Kentucky
Research Site New Orleans Louisiana
Research Site Scarborough Maine
Research Site Annapolis Maryland

+ 621 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05952557 on ClinicalTrials.gov ↗ ← All trials in India