EUCTR2021-005238-40-BE
Active, not recruiting
Phase 1
A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants with Advanced Breast Cancer
ConditionsMetastatic Breast CancerMedDRA version: 20.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10006289Term: Benign and malignant breast neoplasmsSystem Organ Class: 100000004872MedDRA version: 20.0Level: HLTClassification code 10006290Term: Breast and nipple neoplasms malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
DrugsLerociclib
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Metastatic Breast Cancer
- Sponsor
- EQRx, Inc.
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1\. Is capable of giving signed informed consent. This includes compliance with the requirements and restrictions listed in the study informed consent form (ICF) and in this protocol.
- •2\. Must be at least 18 years of age, or the legal age of consent in the jurisdiction in which the study is taking place, at the time of giving signed informed consent.
- •Type of Participant and Disease Characteristics
- •3\. Has a histologically and/or cytologically confirmed diagnosis of estrogen\-receptor positive and/or progesterone receptor\-positive breast cancer by local laboratory.
- •4\. Breast cancer is also HER2\-negative and advanced (locoregionally recurrent; not amenable to curative therapy, eg, surgery and/or radiotherapy; or metastatic) and meets one of the following criteria:
- •Newly diagnosed advanced/metastatic breast cancer, treatment\-naïve.
- •Relapsed with documented evidence of relapse following neoadjuvant (adjuvant) endocrine therapy, with no treatment for advanced/metastatic disease.
- •Relapsed with documented evidence of relapse following completion of adjuvant endocrine therapy, then subsequently progressed with documented evidence of progression after one (1\) line of endocrine therapy (with either tamoxifen or an AI) for advanced/metastatic disease.
- •Newly diagnosed advanced/metastatic breast cancer at diagnosis that progressed with documented evidence of progression after one (1\) line of endocrine therapy (with either tamoxifen, exemestane, or an AI \[other than fulvestrant]).
Exclusion Criteria
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1\. Has symptomatic visceral disease or any disease burden that makes the participant ineligible for endocrine therapy, per the Investigator’s best judgment.
- •2\. Has peritoneal carcinomatosis.
- •3\. Has inflammatory breast cancer at Screening.
- •4\. Has central nervous system (CNS) involvement, unless participant is at least 4 weeks from prior therapy completion to starting study treatment, has stable CNS tumor at the time of Screening, and is not receiving steroids and/or enzyme\-inducing anti\-epileptic medications for brain metastases.
- •5\. Has any clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- •6\. Has a history of prolonged QT syndrome or Torsades de Pointes.
- •Prior/Concomitant Therapy
- •7\. Has received prior treatment with chemotherapy (except neoadjuvant/adjuvant chemotherapy), or with any CDK4/6 inhibitor.
Outcomes
Primary Outcomes
Not specified
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