RightFit
RecruitingPhase 3

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 130 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will be followed for 10 years from randomization of the last patient."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether camizestrant works better than standard hormone-blocking treatment for early breast cancer. It is for adults with ER-positive/HER2-negative cancer who have a medium or high risk of the cancer coming back and have had 2 to 5 years of hormone-blocking treatment after surgery. Study treatment lasts 5 years.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, or the age required by national rules. Women and men may join.
  • Early breast cancer removed by surgery, with a medium or high risk of coming back under the study rules. The cancer must use estrogen to grow (ER-positive) and not have high levels of HER2 protein (HER2-negative).
  • Finished surgery and any needed radiation for the breast cancer. Chemotherapy before or after surgery is allowed.
  • Completed at least 2 years and no more than 5 years of hormone-blocking treatment after surgery, with an extra 3 months allowed at the upper limit. Treatment with a CDK4/6 inhibitor, a drug that slows cancer growth, is allowed.
  • Able to do all usual activities, or limited only in hard physical activity.
  • Organs and bone marrow, which makes blood cells, work well enough.

Who can't join

  • Breast cancer that has spread to distant parts of the body or cannot be removed by surgery because of local spread; or no cancer found in tissue after treatment given before surgery.
  • Another past cancer, unless it has been fully gone without treatment for at least 5 years before study group assignment. Exceptions include non-melanoma skin cancer, noninvasive cancer of the cervix, or cancer the study doctor judges very unlikely to return.
  • Severe or poorly controlled illness that the study doctor thinks would make joining or following the study unsafe or difficult.
  • Known heart pumping strength below 50% with heart failure that limits activity, or a heart test showing a resting QTcF interval above 480 milliseconds, a measure of the heart's electrical timing.
  • Current sex hormone treatment, or other cancer treatment not allowed by the study. Bone medicines called bisphosphonates or RANKL inhibitors are allowed.
  • Past treatment with camizestrant, fulvestrant, or experimental drugs that block or break down estrogen receptors.
  • Pregnant or breastfeeding.
  • Known allergy to camizestrant, its ingredients, or similar drugs. Men and women who have not fully gone through menopause also cannot join if allergy or intolerance prevents use of any LHRH agonist, a hormone-lowering medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 high or intermediate risk of recurrence, based on clinical-pathological risk features, 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 * Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor) * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Adequate organ and 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 at 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 sex hormone therapy * 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 sites (127)

AK

AL

AR

AZ

CA

CO

CT

FL

GA

HI

IA

IL

IN

KY

LA

MA

MD

ME

MI

MO

NC

NE

NH

NJ

NM

NV

NY

OH

PA

RI

SC

SD

TN

TX

UT

VA

WA

WI

WV