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Adjuvant CDK4/6 Inhibitor Use in HR+/HER2- Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWenjin Yin

About this trial

To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged ≥18 and older

Patients with pathologically confirmed breast cancer without distant metastasis or local recurrence

HR+/HER2-

ECOG 0-3

Disqualifiers

During pregnancy or lactation

Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption

Trial population

Breast cancer patients meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CDK4/6 inhibitor

    Drug

    abemaciclib OR ribociclib

Treatment groups

229 Participants
are divided into 1 treatment group
Group A: Adjuvant CDK4/6 inhibitor1 intervention

Trial outcomes

Primary outcomes

1

Invasive Disease-free Survival (iDFS)

Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

Time frame
From the date of surgery until time of event up to 2 years.

Secondary outcomes

1

Disease-free Survival (DFS)

Disease-free survival time is defined as the time from date of surgery until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, non-breast primary invasive cancer, ductal carcinoma in situ (DCIS),or distant recurrence and death from any cause.

Time frame
From the date of surgery until time of event up to 2 years
2

Overall Survival (OS)

Overall survival is defined as the time from surgery to death from any cause.

Time frame
From the date of surgery until time of event up to 2 years
3

Adverse events

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

Time frame
From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wenjin Yin

Lead sponsor

RenJi Hospital

Sponsor institution

Source ClinicalTrials.gov
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