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New treatment option for ER-Positive HER2-Negative Breast Cancer
Official title A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
ClinicalTrials.gov ID: NCT07647328
What this study is testing
What is Camizestrant?
Camizestrant is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for er-positive her2-negative 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
- The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced disease. Participants will be treated within the trial until they discontinue the study treatment for any reason.
- Phase 3: a large, late-stage study
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
- Capable of giving signed informed consent.
- Female or male, must be ≥ 18 years or as per locally allowed age limit for screening. Type of Participant and Disease Characteristics
- Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or...
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- De novo Stage 4 disease, or recurrence from early CD stage breast cancer after having received standard adjuvant endocrine therapy. Note that at...
You likely can't join if
- Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.
- No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.
- Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.
- Persistent treatment-induced non-haematological toxicities (CTCAE Grade \> 2).
- Known active infection including tuberculosis HBV and HCV.
- Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines.
See the full eligibility criteria
- Capable of giving signed informed consent.
- Female or male, must be ≥ 18 years or as per locally allowed age limit for screening. Type of Participant and Disease Characteristics
- Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local laboratory results and who are not amenable to resection or radiation therapy with curative intent.
- Previously untreated with any systemic anti-cancer therapy for their locoregionally recurrent or metastatic ER+ disease.
- De novo Stage 4 disease, or recurrence from early CD stage breast cancer after having received standard adjuvant endocrine therapy. Note that at least 12 months must have elapsed since the patient's last dose of...
- ECOG performance status of 0 or 1.
- Adequate organ and marrow function. Sex and Contraceptive/Barrier Requirements
- For those female or male patients who are not abstinent (in line with their preferred and usual lifestyle choice), and intend to be heterosexually active with a partner: Female patients must be using highly effective...
- Participants who are not clinically indicated for endocrine therapy in combination with the CDK4/6 inhibitor ribociclib.
- No evidence of advanced inoperable disease, or bone only disease with sclerotic/osteoblastic bone lesions only per standard of care imaging.
- Have advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term, and/or pulmonary lymphangitis.
- Persistent treatment-induced non-haematological toxicities (CTCAE Grade \> 2).
- Known active infection including tuberculosis HBV and HCV.
- Known to have tested positive for HIV. Participants with HIV may be enrolled if they fulfil the criteria recommended by FDA and ASCO guidelines.
- Any clinically important abnormalities in heart conduction patterns; participants with pacemakers or medically controlled atrial fibrillation are not excluded.
- Ongoing symptomatic hypotension.
- Pregnant or lactating women or patients not willing to use highly effective contraception as defined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Palo Alto, California, United States
- Marietta, Georgia, United States
- Evanston, Illinois, United States
- Edgewood, Kentucky, United States
- Louisville, Kentucky, United States
- Reno, Nevada, United States
- Sioux Falls, South Dakota, United States
- Nashville, Tennessee, United States
- Fort Worth, Texas, United States
- Kingwood, Texas, United States
- Midlothian, Virginia, United States
- Angers, France
- Bayonne, France
- Bobigny, France
- Caen, France
- Chambray-lès-Tours, France
- Grenoble, France
- Montpellier, France
- Nancy, France
+ 58 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 Duarte, California, United States; Palo Alto, California, United States; Marietta, Georgia, United States; Evanston, Illinois, United States; Edgewood, Kentucky, United States; Louisville, Kentucky, United States and 72 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.