Study Comparing Camizestrant and Palbociclib with Anastrozole and Palbociclib for Patients with ER-Positive, HER2-Negative Advanced Breast Cancer Without Prior Treatment
This clinical trial is focused on studying treatments for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer. The study involves two main treatment combinations. The first combination includes AZD9833, also known as camizestrant, taken with palbociclib. The second combination involves anastrozole with palbociclib. Additionally, some participants may receive a placebo to match the active medications. The purpose of the study is to determine if the combination of AZD9833 and palbociclib is more effective than anastrozole and palbociclib in treating this type of breast cancer.
Participants in the study will receive one of the treatment combinations and will be monitored over a period of time to assess the effectiveness of the treatment. The study is designed to be “double-blind,” meaning neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The treatments are administered orally, and the study will last for a maximum of 26 weeks. Throughout the study, participants will have regular check-ups and tests to monitor their health and the progress of the treatment.
This trial aims to provide valuable information on the best treatment options for patients with this specific type of breast cancer. By comparing the two treatment combinations, researchers hope to find a more effective way to manage the disease and improve patient outcomes. The study is part of ongoing efforts to advance cancer treatment and provide better care for patients with advanced breast cancer.
1randomization
Upon joining the study, participants are randomly assigned to one of two treatment groups. This process is called randomization and ensures that each participant has an equal chance of receiving either treatment option.
2treatment administration
Participants in the first group receive AZD9833 (also known as camizestrant) in combination with palbociclib. AZD9833 is taken orally as a film-coated tablet. Palbociclib is available in different forms, including 75 mg, 100 mg, and 125 mg hard capsules or film-coated tablets, and is also taken orally.
Participants in the second group receive anastrozole in combination with palbociclib. Anastrozole is taken orally as a 1 mg film-coated tablet. Palbociclib is administered in the same forms and dosages as in the first group.
For pre- or peri-menopausal women and men, additional treatment with approved LHRH agonists such as goserelin acetate (administered subcutaneously) or leuprorelin acetate (administered intramuscularly) is required for the duration of the study.
3treatment schedule
The treatment is administered in cycles. Each cycle lasts 28 days. Participants take the oral medications daily as prescribed by the study protocol.
4monitoring and assessments
Throughout the study, regular visits are scheduled to monitor health and assess the effectiveness of the treatment. This includes laboratory tests, imaging studies, and other necessary procedures.
Progression-free survival (PFS) is assessed by the investigator using specific criteria to evaluate the response to treatment.
5study duration
The study is expected to continue until February 2029. Participants remain in the study as long as they benefit from the treatment and do not experience unacceptable side effects.
Who Can Join the Study?
Women who are pre-menopausal or peri-menopausal, or men, can join if they agree to be treated with approved medications called LHRH agonists during the study. These medications help manage hormone levels.
Patients with Stage 4 breast cancer that is either newly diagnosed or has come back after early-stage treatment can participate. They must have had at least 24 months of standard hormone therapy before, with at least 12 months since their last dose of a type of hormone therapy called adjuvant AI therapy, without the cancer getting worse. A 2-week break is needed after the last dose of tamoxifen before starting the study.
Participants must have a confirmed diagnosis of ER+ (Estrogen Receptor-Positive) and HER2- (HER2-Negative) breast cancer, based on local lab results.
They should not have received any previous treatment with systemic anti-cancer therapy for their locally advanced or metastatic ER+ breast cancer.
Participants must have measurable disease, which means the cancer can be measured using specific criteria (RECIST v.1.1), or they must have at least one bone lesion that can be assessed by CT (Computed Tomography) or MRI (Magnetic Resonance Imaging).
They should have an ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, which means they are fully active or have some symptoms but can carry out light work.
Participants need to have adequate function of their organs and bone marrow.
They must be willing and able to attend scheduled visits, follow the treatment plan, and undergo laboratory tests and other study procedures.
Who Cannot Join the Study?
Patients who have a different type of breast cancer that is not Estrogen Receptor-Positive or HER2-Negative. This means the cancer does not grow in response to estrogen or does not have a protein called HER2.
Patients who are not in the specified age range for the study.
Patients who are not part of the specific group the study is focusing on.
Patients who are not female, as the study is designed for female participants.
Patients who are considered part of a vulnerable population, which means they might need special protection or care.
AZD9833 is an experimental medication being studied for its potential to treat advanced breast cancer. It is taken orally and works by blocking the effects of estrogen in the body, which can help slow the growth of certain types of breast cancer cells that rely on this hormone to grow.
Palbociclib is a medication used in combination with other treatments for certain types of breast cancer. It works by inhibiting proteins in cancer cells, which can slow down or stop their growth. This medication is taken orally and is part of a class of drugs known as CDK4/6 inhibitors.
Anastrozole is a medication used to treat breast cancer in postmenopausal women. It works by lowering estrogen levels in the body, which can help slow or stop the growth of some breast cancer cells that need estrogen to grow. This medication is taken orally and is part of a group of drugs called aromatase inhibitors.
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer – This type of breast cancer is characterized by the presence of estrogen receptors on the surface of the cancer cells, which means the cancer cells may receive signals from estrogen that could promote their growth. It is classified as HER2-negative, indicating that the cancer cells do not have an excess of the HER2 protein on their surfaces. This form of breast cancer is considered advanced when it has spread beyond the breast and nearby lymph nodes to other parts of the body. The progression of the disease can vary, but it often involves the cancer spreading to bones, liver, lungs, or brain. The growth and spread of the cancer can lead to various symptoms depending on the organs affected. The disease’s progression is typically monitored through imaging tests and assessments of tumor response to treatment.
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