CAMBRIA - An open-label, randomized Phase III study to assess the efficacy and safety of Camizestrant (AZD9833, a next-generation selective estrogen receptor degrader to be taken orally) compared to an endocrine standard therapy (aromatase inhibitor or tamoxifen) as additional treatment in patients with ER+/HER2- early-stage breast cancer and a medium or high risk of recurrence who have completed definitive locoregional therapy without detectable disease.

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States (ICTRP)

ID di studio ICTRP
NCT05952557 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
CAMBRIA-2 (ClinO-MD) A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) (BASEC)

Titolo accademico
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 (ICTRP)

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

Malattie studiate
Breast Cancer, Early Breast Cancer (ICTRP)

Intervento studiato
Drug: CamizestrantDrug: TamoxifenDrug: AnastrozoleDrug: LetrozoleDrug: ExemestaneDrug: Abemaciclib (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
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. (ICTRP)

non disponibile

Endpoint primari e secondari
Invasive breast cancer-free survival (IBCFS) (ICTRP)

Invasive disease-free survival (IDFS);Distant relapse-free survival (DRFS);Overall survival (OS);Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0);Proportion of time on study treatment with high side-effect burden as measured by the PGI-TT.;Change from baseline and time to deterioration of health-related quality of life as measured by the 2 global QoL items from the EORTC IL-311;Pharmacokinetics (PK) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Austrian Breast and Colorectal Cancer Study Group (ABCSG) (ICTRP)

Contatti aggiuntivi
AstraZeneca Clinical Study Information Center, information.center@astrazeneca.com, 1-877-240-9479 (ICTRP)

ID secondari
2023-504031-41-00, D8535C00001 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05952557 (ICTRP)