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Tests treatment safety and results for Hormon Receptor Positive Breast Cancer
Official title Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
ClinicalTrials.gov ID: NCT07195227
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 hormon receptor positive breast cancer.
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 trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient must be capable of understanding the purpose of the Study and have signed the written informed consent form (ICF) prior to beginning specific...
- Female or male patients ≥ 18 years of age at the time of signing ICF.
- Pre- or peri-menopausal women or men. are eligible if treated with a Luteinizing hormone-releasing hormone (LHRH) analogue. Treatment with a LHRH is...
- Post-menopausal women, defined by any of the following criteria:
- Cessation of menses for at least 12 consecutive months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the...
You likely can't join if
- Formal contraindication to endocrine therapy defined as visceral crisis and/or rapidly or symptomatic progressive visceral disease.
- Current participation in another therapeutic clinical trial.
- Has previously been treated with any SERD, including camizestrant, experimental ETs or fulvestrant.
- Prior systemic therapy for advanced disease.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms...
- History of another primary malignancy except for the following:
See the full eligibility criteria
Who can join
- Patient must be capable of understanding the purpose of the Study and have signed the written informed consent form (ICF) prior to beginning specific protocol procedures.
- Female or male patients ≥ 18 years of age at the time of signing ICF.
- Pre- or peri-menopausal women or men. are eligible if treated with a Luteinizing hormone-releasing hormone (LHRH) analogue. Treatment with a LHRH is recommended for at least 28 days prior to study treatment; if shorter...
- Post-menopausal women, defined by any of the following criteria:
- Cessation of menses for at least 12 consecutive months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in...
- Documented bilateral surgical oophorectomy.
- Documented histologically confirmed HR+ and human epidermal growth factor receptor 2 (HER2)-negative breast cancer according to the most recent American Society of Clinical Oncology (ASCO)/College of American...
- Unresectable locally recurrent or metastatic disease confirmed by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.
- Patients must have received at least five years of adjuvant endocrine therapy, including at least two years of an AI (capped to 30% patients with treatment-free interval [TFI] ≥ 12 months.
- Patients must have:
- Radiological evidence of progression while on, or within 12 months of the end of (neo)adjuvant endocrine therapy (secondary endocrine resistance criteria), or
- Radiological evidence of progression more than 12 months of the end of (neo)adjuvant endocrine therapy (endocrine sensitive criteria).
- Patients receiving a CDK4/6 inhibitor-based therapy in the (neo)adjuvant setting are eligible if disease progression is confirmed more than 12 months following CDK4/6 inhibitor treatment completion in this scenario.
- Evidence of measurable disease as per RECIST v.1.1, or non-measurable, but evaluable, disease, including bone-only disease with at least one lytic or mixed lytic-blastic bone lesion.
- For patients receiving tamoxifen or toremifene, a washout period of 35 days (5 half-lives) prior to randomization is required
- Patients must agree to provide and have available a FFPE tissue biopsy sample taken at the time of presentation with recurrent or metastatic disease. If this is not available, archived primary breast cancer specimen may...
- Adequate bone marrow and organ function:
- Hematological (without platelet, red blood cell transfusion, and/or granulocyte colony-stimulating factor support within seven days before treatment initiation): White blood cell (WBC) count \> 3.0 x 109/L; absolute...
- Hepatic: Serum albumin ≥ 2.5 g/dL; total serum bilirubin \< 1.5 x upper limit of normal (ULN) except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤ 3 x ULN or direct bilirubin...
- Renal: Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min as calculated by Cockcroft- Gault equation.
- Patient must be available and willing to participate in the treatment and follow-up assessments as required.
- Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before Study treatment initiation. In addition, they must agree to use...
- Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable highly effective method of contraception from the time of screening until 21...
- ECOG performance status of 0-1.
- Minimum life expectancy of ≥ 6 months.
What rules you out
- Formal contraindication to endocrine therapy defined as visceral crisis and/or rapidly or symptomatic progressive visceral disease.
- Current participation in another therapeutic clinical trial.
- Has previously been treated with any SERD, including camizestrant, experimental ETs or fulvestrant.
- Prior systemic therapy for advanced disease.
- Known active uncontrolled or symptomatic central nervous system (CNS) metastases and/or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS...
- History of another primary malignancy except for the following:
- Malignancy treated with curative intent with no known active disease ≥ 3 years before the first dose of Study treatment, and of very low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease.
- Other exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin. Note: For other cancers considered to have a low risk of recurrence, discussion with the Medical Monitor is required.
- Known allergy or hypersensitivity reaction to any investigational medicinal products (IMPs) or their incorporated substances. Note: Ribociclib is contraindicated for patients with hypersensitivity/allergy to peanut or...
- History of malabsorption syndrome or other condition that would interfere with enteral absorption (ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass) or results in...
- Palliative radiotherapy with a limited field of radiation within two weeks or with wide field of radiation or radiation to more than 30% of the bone marrow within four weeks prior to Study enrollment.
- Major surgical procedure or significant traumatic injury within 14 days before Study enrollment.
- Known abnormalities in coagulation such as bleeding diathesis, or any history of coagulopathy within six months before Study enrollment, including history of deep vein thrombosis or pulmonary embolism.
- Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.
- Current known infection with human immunodeficiency virus (HIV) detectable viral load, hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a...
- Any other active uncontrolled infection at the time of screening. Known substance abuse or any other concurrent severe and/or uncontrolled psychiatric or medical condition that would, in the Investigator's judgment...
The study team makes the final eligibility decision.
Where it's taking place
- Dessau, Germany
- Alicante, Spain
- Barcelona, Spain
- Girona, Spain
- Granada, Spain
- Jerez de la Frontera, Spain
- León, Spain
- Madrid, Spain
- Málaga, Spain
- Reus, Spain
- Seville, Spain
- Valencia, Spain
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dessau, Germany; Alicante, Spain; Barcelona, Spain; Girona, Spain; Granada, Spain; Jerez de la Frontera, Spain and 6 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.