BridgeMD
New treatment option for Breast Cancer, Early Breast Cancer
Official title An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
ClinicalTrials.gov ID: NCT05952557
What this study is testing
What is Camizestrant?
Camizestrant is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for breast cancer, early breast cancer.
Also referred to as AZD9833.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- 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...
- Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without...
- Patients must be assigned by chance within 12 months of definitive breast surgery.
- Patients may have received up to 12 weeks of endocrine therapy prior to randomisation.
You likely can't join if
- 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...
- 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
See the full eligibility 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 assigned by chance 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dothan, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fayetteville, Arkansas, United States
- Duarte, California, United States
- Fountain Valley, California, United States
- Greenbrae, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Monterey, California, United States
- Walnut Creek, California, United States
- West Hollywood, California, United States
- Aurora, Colorado, United States
- Littleton, Colorado, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Washington D.C., District of Columbia, United States
- Clearwater, Florida, United States
- Fort Myers, Florida, United States
+ 617 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dothan, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fayetteville, Arkansas, United States; Duarte, California, United States; Fountain Valley, California, United States and 631 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.