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A Prospective, Open-label, Randomized Trial Comparing Switch to A1811 Versus Continued THP Neoadjuvant Therapy After THP Induction in HER2-Positive Breast Cancer

ConditionBreast Cancer (Early Breast Cancer)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorPeking University People's Hospital

About this trial

This is a multicenter, open-label, randomized controlled trial. A total of 432 eligible patients with HER2-positive breast cancer will be enrolled after screening. All patients will receive THP-based neoadjuvant therapy (THP) for 2 cycles. After 2 cycles, imaging-based response will be assessed according to RECIST v1.1. Patients with a response or stable disease (PR or SD) will be randomized 1:1 into the experimental group or the control group. Randomization occurs after the 2-cycle assessment. Experimental group: Switch to A1811 therapy for 4 cycles. Control group: Continue the THP regimen for 4 cycles. After completing a total of 6 cycles of neoadjuvant therapy, all patients will undergo definitive surgical treatment for pathological assessment. Primary endpoint: Pathologic complete response (pCR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • A1811

    Drug

    Switch to A1811 therapy for 4 cycles

  • THP

    Drug

    Continue the THP regimen for 4 cycles

Treatment groups

432 Participants
are divided into 2 treatment groups
Group A: swithing to A1811Experimental treatment 1 intervention
Group B: THPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

pCR

After completion of neoadjuvant therapy, patients underwent definitive surgical resection; histopathological assessment of the hematoxylin and eosin-stained excised breast cancer specimens and all ipsilateral lymph node samples showed no residual invasive cancer.

Time frame
From enrollment to the end of treatment at 6 months

Secondary outcomes

1

ORR

The proportion of subjects achieving CR or PR as the best tumor response during neoadjuvant therapy. The investigators will assess objective response rate (ORR) according to RECIST v1.1.

Time frame
From enrollment to the end of treatment at 6 months
2

EFS

Time from randomization to the first occurrence of any of the following events: disease progression prior to surgery, local or distant recurrence after surgery, or death from any cause.

Time frame
From enrollment to the end of treatment at 5 years
3

OS

he time from randomization to death from any cause.

Time frame
From enrollment to the end of treatment at 5 years
4

AE rate

AEs were graded according to NCI-CTCAE v5.0. Descriptive statistics were summarized by treatment group for: any AE, AEs ≥ Grade 3, SAEs, drug-related AEs, drug-related SAEs, AEs leading to dose modification, and AEs leading to discontinuation of therapy. For each category, the number of patients with at least one event and the proportion (with 95% CI) of the corresponding total evaluable patients in each group were reported.

Time frame
From enrollment to the end of treatment at 4 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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