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Un estudio para evaluar la eficacia y seguridad de múltiples combinaciones de tratamientos en pacientes con cáncer de mama (MORPHEUS-Cáncer de mama)
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Cáncer Cáncer de mama Cáncer de mama inoperable Cáncer de mama Er-positivo Locally Advanced or Metastatic Breast Cancer
Detalles básicos
Mujer
≥18 Años
No
Promotor del estudio
Hoffmann-La Roche
Fase
Fase I/Fase II
Código del estudio
NCT04802759, CO42867, 2020-004889-19,2023-507495-48-00
How does the Morpheus Breast Cancer clinical trial work?
This clinical trial is recruiting people who have a type of disease called breast cancer. In order to take part, patients must have inoperable, locally advanced or metastatic, estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
The purpose of this clinical trial is to compare the effects, good or bad, of abemaciclib, ipatasertib, inavolisib, ribociclib or everolimus plus giredestrant versus giredestrant alone on patients with ER+, HER2- breast cancer. In this clinical trial, you will get either abemaciclib, ipatasertib, inavolisib, ribociclib or everolimus plus giredestrant or giredestrant alone.
The study is designed with the flexibility to open new treatment arms, as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have,
Performance Status of 0 or 1as defined by Eastern Cooperative Oncology Group (ECOG)
Documented estrogen receptor-positive (ER+) tumor
Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer
Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)
Postmenopausal status for women
Life expectancy ≥3 months
Availability of a representative tumor specimen that is suitable for evaluation of Ki67, and/or additional biomarkers via central testing
Prior fulvestrant therapy is allowed
Measurable disease
Adequate hematologic and end-organ function
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
You must not have,
Known HER2-positive breast cancer
Prior treatment with cytotoxic chemotherapy for metastatic breast cancer
Concurrent hormone replacement therapy
Prior treatment with any of the protocol-specified study treatments
Treatment with investigational therapy within 28 days prior to initiation of study treatment
Systemic treatment for ER+ breast cancer within 2 weeks of Cycle 1, Day 1 or 5 half-lives of the drug prior to Cycle 1, Day 1
Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 or better, with the exception of alopecia of any grade and Grade ≤2 peripheral neuropathy
Prior allogeneic stem cell or solid organ transplantation
Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
Uncontrolled tumor-related pain
Uncontrolled or symptomatic hypercalcemia
Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
History of leptomeningeal disease
Active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
Active cardiac disease or history of cardiac dysfunction
Positive HIV test at screening or at any time prior to screening
Active Hepatitis B or Hepatitis C virus infection
Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery, including gastric resection, potentially affecting enteral absorption
Known allergy or hypersensitivity to any of the study drugs or any of their excipients
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page. You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again. Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part. While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
Giredestrant, given as a pill once a day for each 28 day cycle, alone or in combination with any one of the following drugs:
- Abemaciclib, given as a pill twice a day for each 28 day cycle, or
- Ipatasertib, given as a pill once a day on days 1-21 for each 28 day cycle, or
- Inavolisib, given as a pill once a day for each 28 day cycle, or
- Ribociclib, given as a pill once a day on days 1-21 for each 28 day cycle, or
- Everolimus, given as a pill once a day for each 28 day cycle
Each group may open and close for recruitment at different times. Your chances of being placed in any group depends on how many groups are open at a given time, with no more than 35 in 100 chance of being placed in the control group.
How often will I be seen in follow-up appointments, and for how long?
You will be given the clinical trial treatment for as long as it can help you. You are free to stop this treatment at any time. After being given treatment, you will still be seen regularly by the clinical trial doctor every 28 days. Occasionally, clinic visits may occur more frequently. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor may suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04802759
Trial-identifier: NCT04802759
La siguiente información proviene de la página web de acceso público ClinicalTrials.gov y ha sido editada con un lenguaje más comprensible.
La siguiente información se origina en el sitio web de acceso público ClinicalTrials.gov y no ha sido modificada.
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