Health TrialsbyHealthPanel

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

ConditionsEarly Breast CancerAdjuvant TherapyHormone Receptor Positive / HER2-negative Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFujian Cancer Hospital

About this trial

This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer.

It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy.

The primary endpoint is 3-year invasive disease-free survival (iDFS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female breast cancer patients aged ≥ 18 years, who are postmenopausal or premenopausal/perimenopausal;

Histologically confirmed HR-positive, HER2-negative early-stage breast cancer (immunohistochemical detection shows ER ≥ 10% and/or PR ≥ 10%, HER2 0-1+ or HER2 ++ but negative and non-amplified by FISH or CISH detection);

Histologically confirmed invasive breast cancer with postoperative pathological stage II-III;

Patients with or without prior neoadjuvant chemotherapy or adjuvant chemotherapy are eligible for enrollment;

Disqualifiers

Stage IV breast cancer, recurrent or metastatic breast cancer, or inflammatory breast cancer;

A history of any malignant tumor, or having received anti-tumor treatment or radiotherapy for any malignant tumor in the past, excluding cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin;

Concurrent participation in other clinical trials;

Having received blood transfusion or treatment with colony-stimulating factors, etc. within 2 weeks before enrollment;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dalpiciclib

    Drug

    Dalpiciclib 100 mg orally, daily on days 1-21 of a 28-day cycle, for 3 years.

  • Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

    Drug

    Standard adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitor), as per physician's choice.

  • Dalpiciclib

    Drug

    Dalpiciclib 125 mg orally, daily on days 1-21 of a 28-day cycle, for 2 years.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: 2-Year Dalpiciclib 125 mg + Endocrine TherapyExperimental treatment 2 interventions
Group B: 3-Year Dalpiciclib 100 mg + Endocrine TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

3-years Invasive Disease-Free Survival (iDFS)

Time frame
36 months from randomization

Secondary outcomes

1

Distant Disease-Free Survival (DDFS)

Time frame
Up to 48 months
2

Overall Survival (OS)

Time frame
up to 48 months
3

Incidence and Severity of Adverse Events

According to Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0)

Time frame
From treatment initiation to 30 days after the last dose, up to approximately 36 months
4

Patient-Reported Outcomes (PROs)

EORTC QLQ-C30 (version 3.0) Quality of Life Questionnaire. The scores of each domain in the scale need to be converted into a 0 - 100 scale through standardized calculation: Functional domains: Higher scores indicate better functional status. Symptom domains: Higher scores indicate more severe symptoms. Global quality of life: Higher scores indicate a better quality of life.

Time frame
Baseline to end of follow-up (up to 48 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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