A study to evaluate the safety and efficacy of Lerociclib in participants with advanced breast cancer.

Phase 1

• Conditions: Metastatic breast cancer; MedDRA 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: 100000004872; MedDRA 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]

• Registration Number: EUCTR2021-005238-40-IT
• Lead Sponsor: EQRx International, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-14
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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]).
Please refer to the Protocol for further inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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.
Please refer to the Protocol for further exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified