Abemaciclib for ER+/HER2- Breast Cancer

Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

Recruiting Phase 3 Interventional Study
Breast Cancer
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 – 80
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,900 (estimated)
Sponsor
Fudan University · Other
Who this trial is looking for

This trial is looking for women aged 18-80 with specific types of breast cancer and 1-3 positive lymph nodes. Participants will receive a treatment called abemaciclib for three years and will help researchers understand if chemotherapy can be avoided.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am a woman aged 18-80 years old.
  • I have localized invasive breast cancer with 1-3 positive lymph nodes.
  • I have been tested and my cancer is ER+/HER2-.
  • My tumor has estrogen receptor levels of at least 50%.
  • I have a performance status of 0 or 1.
  • I have good blood cell and organ function.
  • I have signed consent to participate.

You may not be able to join if

  • I have received any neoadjuvant therapy before my surgery.
  • I have bilateral breast cancer.
  • I have a history of other cancers, except for certain types.
  • I have metastatic breast cancer.
  • I have a serious heart or organ condition.
  • I am pregnant or breastfeeding, or cannot use effective contraception.
  • I have a severe or uncontrolled infection.
  • I am currently participating 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.

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About This Trial

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * women aged 18-80 years old; * Patient has localized invasive breast carcinoma with1-3 positive lymph nodes, T1-T2,and is ER+/HER2- confirmed by histopathology after early breast cancer surgery#HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a ne…
Contacts

Zhimin Shao, MD, PhD

+86-021-64175590

zhimingshao@yahoo.com

CONTACT

Yin Liu, MD

+8664175590

liuyinfudan@163.com

CONTACT