Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Exemestane

Letrozole

Anastrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

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

Camizestrant. Experimental. Administered orally

Camizestrant

Tamoxifen. Comparator. Administered per local approved label

Anastrozole. Comparator. Administered per local approved label

Letrozole. Comparator. Administered per local approved label

Exemestane. Comparator. Administered per local approved label

AstraZeneca Clinical Study Information Center

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.

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 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. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).

Patients will be followed for 10 years from randomization of the last patient.

Patients will be randomised in a 1:1 ratio to one of the following arms:

* Arm A: Continue standard ET of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen)
* Arm B: Camizestrant

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

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IBCFS is defined as time from randomisation until date of first occurrence of:

* Invasive ipsilateral breast tumour recurrence (invasive IBTR)
* Locoregional invasive breast cancer recurrence
* Distant recurrence
* Invasive contralateral breast cancer
* Death attributable to any cause.

IDFS is defined as time from randomisation until date of first occurrence of one of the following events:

* Invasive ipsilateral breast tumor recurrence (invasive IBTR)
* Locoregional invasive breast cancer recurrence
* Distant recurrence
* Invasive contralateral breast cancer
* Second primary non-breast invasive cancer
* Death attributable to any cause.

DRFS is defined as time from randomisation until date of first distant recurrence or death from any cause, whichever occurs first.

OS is defined as time from randomisation until death from any cause.

• Plasma concentrations of camizestrant pre-dose (Ctrough)( trough concentration)

AstraZeneca

Symptoms and General Pathology

Recurrence

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

Tamoxifen. Comparator. Administered orally

Anastrozole. Comparator. Administered orally

Letrozole. Comparator. Administered orally

Exemestane. Comparator. Administered orally

Abemaciclib adjuvant treatment Administered orally

Abemaciclib

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.

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 of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).

Patients will be followed for 10 years from randomization of the last patient.

Patients will be randomised in a 1:1 ratio to one of the following arms: • Arm A: Standard ET of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib • Arm B: Camizestrant ± abemaciclib

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

CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IBCFS is defined as time from randomisation until date of first occurrence of:

* Invasive ipsilateral breast tumour recurrence
* Locoregional invasive breast cancer recurrence
* Distant recurrence
* Contralateral invasive breast cancer
* Death attributable to any cause.

IDFS is defined as time from randomisation until date of first occurrence of one of the following events:

* Invasive ipsilateral breast tumor recurrence
* Locoregional invasive breast cancer recurrence
* Distant recurrence
* Contralateral invasive breast cancer
* Second primary non-breast invasive cancer
* Death attributable to any cause.

Plasma concentrations of camizestrant pre-dose (trough concentration)

Austrian Breast and Colorectal Cancer Study Group (ABCSG)

Trastuzumab

Mitogens

Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment

No intervention

Clinical Trials

This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy	NCT05774951	Breast Cancer, ...	Camizestrant Tamoxifen Anastrozole Letrozole Exemestane	18 Years - 130 Years	AstraZeneca
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)	NCT05952557	Breast Cancer, ...	Camizestrant Tamoxifen Anastrozole Letrozole Exemestane Abemaciclib	18 Years - 130 Years	AstraZeneca
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer	NCT02443467	Breast Cancer, ...	No intervention	18 Years -	Hoffmann-La Roche
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer	NCT02443467	Breast Cancer, ...	No intervention	18 Years -	Hoffmann-La Roche

Spots Global Cancer Trial Database for breast cancer, early breast cancer