CDK4/6 Inhibitors with Endocrine Therapy for Early Breast Cancer

CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients(CHESS)

Recruiting Phase 3 Interventional Study
Breast Cancer Adjuvant Therapy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,903 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for

This trial is looking for women with early-stage breast cancer that is hormone receptor positive and HER2 positive. Participants will receive a combination of a new treatment and standard therapy to see if it improves outcomes.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 18 to 70
  • I have been diagnosed with HR+/HER2+ breast cancer
  • I have had surgery for my breast cancer
  • I completed anti-HER2 targeted therapy within the last year
  • I have normal function of my major organs
  • I can use birth control if I can get pregnant
  • I agree to participate in the trial

You may not be able to join if

  • I have breast cancer in both breasts
  • I have cancer that has spread to other parts of my body
  • I have a history of serious heart problems in the last 6 months
  • I am currently pregnant or breastfeeding
  • I have a severe infection
  • I have active hepatitis B or C
  • I have a history of drug abuse or psychiatric disorders
  • I am enrolled in another clinical trial

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: 1. Females aged ≥18 and ≤70 years. 2. ECOG systemic status grade 0 to 1. 3. Histologically confirmed invasive HR+/HER2+ breast cancer (Specific definition: breast cancer patients whose estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor…
Contacts

Zhimin Shao, MD, PhD

+86-021-64175590

zhi_ming_shao@163.com

CONTACT

min he

zhi_ming_shao@163.com

CONTACT