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NCT Number: NCT06301438

Dalpiciclib in HR+/HER2- ABC

To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.

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Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed advanced breast cancer
  • Hormone receptor-positive and human epidermal growth factor receptor 2-negative
  • ECOG 0-1

Exclusion criteria

  • Pregnant or breastfeeding
  • History of immunodeficiency

Treatment and study plan

Dalpiciclib

Drug

dalpiciclib oral day 1-21, every 28 days

Primary outcomes

  1. Progression-Free Survival

    Time frame: From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)

    The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.

Secondary outcomes

  1. Adverse events

    Time frame: From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year)

    Adverse events during dalpiciclib treatment will be assessed according to the NCI CTCAE v5.0.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Official study title

Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 8, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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