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Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer

ConditionHR Positive HER2 Negative Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
Sponsorwanghaibo

About this trial

This study is a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast cancer. A centralized randomization system (IWRS) will be used for randomization, and stratification will be performed based on the following factors during randomization: 1) Visceral metastasis (yes vs no); 2) Disease-free interval (previously untreated vs 12 \< DFI ≤ 24 vs DFI \> 24).

Cohort A: Dalpiciclib 125mg + Letrozole 2.5mg Cohort B: Dalpiciclib 150mg + Letrozole 2.5mg Imaging assessment will be conducted in accordance with the RECIST 1.1 criteria, and tumor imaging evaluation will be performed by investigators from the participating centers.

Patients receiving dalpiciclib will undergo a safety visit 28 days after the last dose, followed by survival follow-up until the patient's death or trial termination (whichever comes first).

Pharmacokinetic assessment: Blood samples will be collected once before dosing on Cycle 1 Day 15 (C1D15), 4 hours after dosing on C1D15, before dosing on Cycle 2 Day 1 (C2D1), and before dosing on Cycle 4 Day 1 (C4D1) to explore the population pharmacokinetic characteristics of dalpiciclib and the factors affecting its pharmacokinetics. The first dosing time of the subjects, each blood collection time, the dalpiciclib dosing time within three days before blood collection, and the dalpiciclib dosing time on the day of C1D15 blood collection must be accurately recorded. If dalpiciclib is not administered within 14 days before the planned PK blood collection, no PK blood collection will be performed on the day of that visit. If possible, PK samples should be collected simultaneously with samples for other laboratory tests.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have undergone bilateral oophorectomy in the past, or be aged ≥60 years; or

Aged <60 years, in a natural postmenopausal state (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), with E2 and FSH at postmenopausal levels; or

Premenopausal or perimenopausal female patients can also be enrolled, but must be willing to receive LHRH agonist treatment during the study period

Patients with breast cancer confirmed by pathological examination to be HR-positive and HER2-negative, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiotherapy with the goal of cure, and without clinical indications for chemotherapy.

Disqualifiers

Have given informed consent and signed the informed consent form, and be willing and able to comply with the planned visits, study treatment plan, laboratory tests and other trial procedures

Previously diagnosed with HER2-positive breast cancer by pathological examination

Inflammatory breast cancer

Disease progression or recurrence at 12 months or within 12 months after completion of previous neoadjuvant or adjuvant endocrine drug treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dalpiciclib 125mg

    Drug

    Oral administration, 125mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest

  • Dalpiciclib 150mg

    Drug

    Oral administration, 150mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest

  • Letrozole 2.5mg

    Drug

    Oral administration, 2.5mg, administered once daily until disease progression or unacceptable toxicity

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Cohort A: Dalpiciclib 125mgExperimental treatment 2 interventions
Group B: Cohort B: Dalpiciclib 150mgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression - Free Survival (PFS)

Progression - Free Survival (PFS) is registered as 'Primary' as the most clinically impactful endpoint; other outcomes (ORR, DoR) are secondary per platform requirements, though protocol does not hierarchy

Time frame
From date of randomization until the date of first documented disease progression or death from any cause (whichever comes first), assessed per RECIST 1.1 criteria up to 104 weeks
2

Duration of Response (DoR)

Time from first documentation of complete response (CR) or partial response (PR) to disease progression (per RECIST 1.1) or recurrence, assessed by investigators via imaging

Time frame
From the date of first documented complete response (CR) or partial response (PR) (per RECIST 1.1, assessed by investigators via imaging) until the date of first documented disease progression (per RECIST 1.1) or recurrence, assessed up to 104 weeks

Secondary outcomes

Other outcomes

1

Objective Response Rate, ORR

Proportion of participants with complete response (CR, disappearance of all target lesions) or partial response (PR, ≥ 30% reduction in sum of target lesion diameters) per RECIST 1.1.

Time frame
From date of randomization until the date of first documented disease progression or trial completion (whichever comes first), assessed per RECIST 1.1 criteria up to 104 weeks
2

Overall Survival (OS)

Time from randomization to death from any cause, with survival status monitored until trial completion or participant withdrawal.

Time frame
From date of randomization until the date of death from any cause, assessed up to 208 weeks (4 years)
3

Patient - Reported Outcome (PRO): Quality of Life

Quality of life assessed via EORTC QLQ - C30 questionnaire (score range: 0-100; for functional domains, higher scores indicate better quality of life; for symptom domains, higher scores indicate more severe symptoms), focusing on physical, emotional, and functional well - being. Administered at baseline, then every 3 weeks during treatment until trial completion.

Time frame
From baseline, then every 3 weeks during study treatment, until the date of trial completion (assessed up to 104 weeks)]
4

Safety: Adverse Event Profile

Adverse events (AEs) assessed by CTCAE v5.0 criteria, including type, severity, and duration. Monitored from first dose until 30 days after last dose

Time frame
From first dose until 30 days after last dose, monitored continuously

Sponsors and contacts

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

wanghaibo

Lead sponsor

The Affiliated Hospital of Qingdao University

Sponsor institution

Source ClinicalTrials.gov
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