Real-world outcomes of CDK4/6 inhibitors plus hormone therapy for HR+/HER2- advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center real-world study will collect clinical and case data from patients with HR+/HER2- advanced breast cancer treated with CDK4/6 inhibitors plus endocrine therapy between March 2022 and March 2025. Researchers will compare efficacy and safety across different CDK4/6 agents (including palbociclib, abemaciclib, ribociclib, and dalpiciclib) when given with endocrine therapy. The study will summarize subsequent treatment choices after progression and develop a predictive model to forecast response to post‑CDK4/6 therapies. Selected patients may provide tumor or blood samples for genomic and transcriptomic analyses to support translational research on resistance mechanisms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Patients diagnosed with HR+/HER2- (as defined by the ASCO/CAP guidelines) advanced breast cancer who were treated in our hospital from March 2022 to March 2025;
3. Received CDK4/6 inhibitors (including but not limited to the four currently marketed ones: palbociclib, abemaciclib, ribociclib, and dalpiciclib) as advanced-stage treatment for at least one cycle;
4. Have complete medical history records, including demographic information, pathological reports, treatment records, laboratory test results, and imaging examination reports, etc.

Exclusion Criteria:

1. Incomplete medical history data.
2. Only received CDK4/6 inhibitors monotherapy.
3. Received CDK4/6 inhibitors as neoadjuvant/postoperative adjuvant intensification therapy.

Where it's running

• Tianjin Medical University Cancer Insititute and Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Yehui Shi, MD
• Email: shiyehui@tjmuch.com
• Phone: 022-23340123-3252

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Gyrotonic exercise for elders with breast cancer and Behcet disease

  We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.

  Recruiting Cairo University · Giza, Dokki · NCT07929116

• PECS II vs SPSIP nerve blocks for pain after mastectomy

  This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.

  Recruiting Bursa City Hospital · Nilufer, Bursa · NCT07929090

• CG-7321: a first-in-human test in advanced solid tumors

  We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.

  Recruiting at 4 sites Phase 1 Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. · Fuzhou, Fujian and 3 other locations · NCT07923214

• Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

  This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.

  Recruiting Sir Run Run Shaw Hospital · Hangzhou, Zhejiang and 21 other locations · NCT07920094

• Different skin care approaches to prevent skin reactions after mastectomy radiation

  This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07918989

• 3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy

  This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.

  Recruiting Region Skane · Lund, Skåne County · NCT07916337

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.