Efficacy of TQB2102 Versus TCbHP in Neoadjuvant Therapy for HER2-positive Early Breast Cancer.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHenan Cancer Hospital

About this trial

The aim of this study is to evaluate the efficacy and safety of TQB2102 compared to TCbHP in the neoadjuvant treatment of HER2-positive breast cancer. Participants will randomly assigned, in a 1:1 ratio, to receive either TQB2102 or TCbHP for 6 cycles. Patients will undergo definitive surgery (breast conservation or mastectomy with sentinel lymph-node evaluation or axillary dissection) 3 to 6 weeks after the last cycle of the neoadjuvant phase. Primary endpoint is pathological complete response, defined as pathological stage ypT0/Tis ypN0 at the time of definitive surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-70 years,

ECOG performance status 0-1;

Clinical T2-T4, or T1c with axillary lymph node metastasis; Confirmed HER2-positive status (per 2018 ASCO/CAP HER2 Testing Guidelines, defined as IHC 3+ or FISH positive);

Clinically measurable lesion: Lesion measurable by ultrasound, mammography, or optional MRI within 1 month before randomization;

Disqualifiers

Stage IV (metastatic) breast cancer;

Prior treatments received including chemotherapy, endocrine therapy, targeted therapy, or radiotherapy; History of other malignancies within 3 years or concurrent malignancies. Exceptions: Other malignancies treated with surgery alone achieving ≥5-year disease-free survival (DFS) . Cured cervical carcinoma in situ or non-melanoma skin cancer;

Major non-breast cancer-related surgical procedures within 4 weeks prior to enrollment, or incomplete recovery from such procedures;

Significant cardiac disease or conditions including but not limited to: History of heart failure or systolic dysfunction (LVEF <50%). Uncontrolled high-risk arrhythmias: Atrial tachycardia, resting heart rate >100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (Mobitz II second-degree or third-degree AV block). Angina requiring anti-anginal medication. Clinically significant valvular heart disease. ECG evidence of transmural myocardial infarction. Poorly controlled hypertension (SBP >180 mmHg and/or DBP >100 mmHg);

Trial design

Design model

Parallel

Treatments tested in this trial

  • TQB2102

    Drug

    TQB2102 is administered intravenously at 6 mg/kg every 3 weeks for 6 cycles.

  • Docetaxel + Carboplatin + Trastuzumab +Pertuzumab

    Drug

    Docetaxel 75 mg/m2(day 1) , Carboplatin (AUC=6) (day 1), Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Pertuzumab (840mg first dose, 420mg/kg sequential) are administered intravenously every 3 weeks for 6 cycles.

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: TQB2102 groupExperimental treatment 1 intervention
Group B: TCbHPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pathological Complete Response (pCR)

pCR was defined as ypT0/Tis ypN0 at surgery

Time frame
up to 180 days

Secondary outcomes

1

Event-Free Survival (EFS)

EFS was defined as time from randomization to invasive progression (local/distant), recurrence, or death.

Time frame
5-10 years
2

Adverse Event (AE)

Time frame
up to 180 days
3

Overall Survival (OS)

OS was measured from randomization to death from any cause. Patients without documented death were censored at the last contact date.

Time frame
5-10 years
4

Objective Response Rate (ORR)

Time frame
up to 180 days

Other outcomes

1

PCR in Pre-Specified subgroup analysis

PCR in subgroups defined by HR status,HER2 IHC and clinical stages

Time frame
up to 180 days

Sponsors and contacts

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