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RecruitingPhase 2

Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe camizestrant and atirmociclib are when taken together and how well women tolerate them. It is for women with advanced breast cancer that is ER-positive (uses estrogen to grow) and HER2-negative (does not have high levels of HER2 protein), who have already received a CDK4/6 inhibitor, a type of cancer drug.

A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4/6 (CDK4/6) inhibitor.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have breast adenocarcinoma, a cancer that starts in gland tissue, confirmed by tissue or cell testing. Have already received suitable treatment for the cancer type and stage.
  • Have cancer that has spread or returned near the breast, with scans or other clear evidence that it worsened during or after the last whole-body treatment.
  • Be fully active or able to do light work, and be expected to live at least 12 weeks.
  • Have at least one cancer area that can be checked before treatment and again during the study using scans, X-rays, or a physical exam.
  • If you have not gone through menopause, start a GnRH agonist, a drug that lowers hormone levels, at least 4 weeks before study treatment and keep taking it during the study.
  • If you have gone through menopause, meet one of these rules: both ovaries removed; age 60 or older; age 50 or older with a uterus, no hormone therapy, and no periods for at least 12 months; or under age 60 with no periods for at least 12 months and hormone tests showing menopause.
  • If you could become pregnant, agree to use one highly effective birth control method.
  • Have records showing an ER-positive tumor. Progesterone receptor status does not matter.

Who can't join

  • Have received two or more courses of CDK4/6 inhibitor treatment for advanced cancer.
  • Have already received camizestrant or atirmociclib for advanced cancer.
  • Have received other newer SERDs, drugs that break down estrogen receptors, or other experimental hormone treatments for advanced cancer.
  • Have received other experimental CDK inhibitors, drugs that block proteins involved in cell growth.
  • Cannot swallow medicines.
  • Still have moderate or worse side effects from earlier cancer treatment, other than hair loss.
  • Have life-threatening cancer spread to internal organs, or a severe or uncontrolled illness affecting the body.
  • Have a medical reason you cannot take camizestrant or atirmociclib, or a known allergy or intolerance to either drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Main Inclusion Criteria: * Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease. * Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products. * Eastern cooperative oncology group (ECOG)/World Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks. * At least one lesion that is measurable and/or non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination. * Menopausal status * Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study. * Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \<60 years with ≥12 months amenorrhea and post-menopausal hormone levels. * Histological or cytological confirmation of adenocarcinoma of the breast. * Participants of childbearing potential must agree to use one highly effective contraceptive measure. * Documentation of ER-positive tumor irrespective of progesterone receptor status. Main Exclusion Criteria: * A participant who has received 2 or more lines of CDK4/6 inhibitors in the advanced disease setting. * A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting. * Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting. * Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible. * Inability to swallow oral medications. * Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia). * Presence of life-threatening metastatic visceral disease. * Any evidence of severe or uncontrolled systemic diseases. * Contraindication to or known intolerance/hypersensitivity of/to camizestrant or atirmociclib.

Study sites (3)

MO

RI

TN