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Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer

ConditionsBreast CancerAdjuvant Therapy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age65+
SponsorFudan University

About this trial

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, HR+/HER2- breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥4 positive lymph nodes

Disqualifiers

1. Patients who have received neoadjuvant therapy (including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy

    Drug

    Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.

  • CDK4/6 Inhibitor

    Drug

    All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)

  • Endocrine therapy

    Drug

    Endocrine therapy (letrozole/anastrozole/exemestane)

Treatment groups

1,244 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 3 interventions
Group B: Chemo-freeExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

5-years Invasive disease free survival

5-year invasive disease-free survival (iDFS), defined as the time from randomization to the first occurrence of: local recurrence, distant metastasis, contralateral invasive breast cancer, death from any cause.

Time frame
5 years

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Approximately 5 years
2

Safety including adverse events (AEs), severe adverse events (SAEs) and adverse events of special interest (AESI).

Incidence of AEs, SAE, AESIs (interstitial lung disease, LVEF decrease), AEs resulting in study intervention interruption and discontinuation, etc.

Time frame
Up to approximately 3 years
3

Geriatric assessment (G-8)

• Modified Geriatric-8 (G-8) screening tool

Time frame
Up to approximately 3 years
4

Clinical Frailty Scale

Clinical Frailty Scale (CFS, version 2.0)

Time frame
Up to approximately 3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: