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.
Summary description of the study
Study duration: The study consists of three phases: - a pre-screening phase lasting up to 28 days - the treatment phase lasting up to 7 years - health follow-ups of study participants for up to 10 years after the last person is enrolled in the study. This means that participation in the study can last up to 10 to 13 years. Pre-screening phase Before the study treatment can begin, a series of examinations must be performed, which may require several visits to the doctor or specialists. The pre-screening phase can take up to 28 days. The doctor will not conduct any study-specific tests or examinations before the participant has signed the informed consent form. If possible, the principal investigator will use examination results and tissue samples from the time prior to the pre-screening. Study treatment Participants who meet the inclusion criteria during the pre-screening will be randomly assigned to a study arm (Arm A or Arm B) with the corresponding treatment. Random assignment means that the treatment is assigned randomly, like flipping a coin or drawing names from a hat. The probability is fifty-fifty.
(BASEC)
Intervention under investigation
Study treatment
This is an open-label study, meaning that the participant and the principal investigator will know which treatment is being administered:
- Participants in Arm B will receive 75 mg of the investigational drug Camizestrant (tablet, to be taken orally once daily).
- Participants in Arm A will receive the standard hormonal therapy (also to be taken orally once daily). The principal investigator will determine the hormonal therapy, either an aromatase inhibitor (Anastrozole 1 mg, Letrozole 2.5 mg) or Tamoxifen 20 mg.
Participants in both arms may receive additional Abemaciclib if needed. All these options will be discussed in detail with the participant.
(BASEC)
Disease under investigation
ER+/HER2- early-stage breast cancer
(BASEC)
- Documented, histologically confirmed ER+/HER2- early-stage invasive breast cancer surgically removed without signs that the cancer has metastasized in the body. - Age of the participant at the time of inclusion in the study: ≥18 years - The participant has signed the informed consent. (BASEC)
Exclusion criteria
Participants cannot take part if they - have inoperable locally advanced breast cancer without known metastases in the body - have a pathologically complete response or residual tumor burden after treatment with neoadjuvant chemotherapy (treatment given to reduce tumor mass before a planned surgical intervention) - have a history of another cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix or with very low risk of recurrence), unless the cancer has completely regressed without treatment for at least 5 years prior to the date of inclusion in the study. (BASEC)
Trial sites
Basel, Bellinzona, Chur, Lausanne, Luzern, St. Gallen, Winterthur, Zurich, Other
(BASEC)
Baden, Frauenfeld, La Chaux-de-Fonds, Münsterlingen
(BASEC)
Sponsor
Astra Zeneca AB, Sweden Swiss Group for Clinical Cancer Research (SAKK), Bern
(BASEC)
Contact
Contact Person Switzerland
Dr. Jana Musilova
+41 31 389 91 91
trials@cluttersakk.chSwiss Group for Clinical Cancer Research (SAKK)
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
28.03.2024
(BASEC)
ICTRP Trial ID
NCT05952557 (ICTRP)
Official title (approved by ethics committee)
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)
Academic title
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)
Public title
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) (ICTRP)
Disease under investigation
Breast Cancer, Early Breast Cancer (ICTRP)
Intervention under investigation
Drug: CamizestrantDrug: TamoxifenDrug: AnastrozoleDrug: LetrozoleDrug: ExemestaneDrug: Abemaciclib (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion 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
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Austrian Breast and Colorectal Cancer Study Group (ABCSG) (ICTRP)
Additional contacts
AstraZeneca Clinical Study Information Center, information.center@astrazeneca.com, 1-877-240-9479 (ICTRP)
Secondary trial IDs
2023-504031-41-00, D8535C00001 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05952557 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available