A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

Hengrui Medicine

Status and phase: Enrolling; Phase 3

Conditions: HER2-PositiveRecurrent or Metastatic Breast Cancer

Treatments: Drug: SHR-A1811 Injection ； Pertuzumab Injection; Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection; Drug: SHR-A1811 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06057610

SHR-A1811-307

Details and patient eligibility

About

To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer

Enrollment: 864 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Women aged 18 to 75 (inclusive)
2. HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1
4. An expected survival of ≥ 12 weeks
5. At least one measurable lesion according to RECIST v1.1 criteria
6. Have adequate renal and hepatic function
7. Patients voluntarily joined the study and signed informed consent

Exclusion criteria

1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
4. Presence with uncontrollable third space effusion
5. Have undergone other anti-tumor treatment within 4 weeks before the first dose
6. A history of immune deficiency
7. Clinically significant cardiovascular disorders
8. Known or suspected interstitial lung disease
9. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
10. Known hereditary or acquired bleeding tendency
11. Active hepatitis and liver cirrhosis
12. Presence of other serious physical or mental diseases or laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

864 participants in 3 patient groups

Treatment group A: SHR-A1811 Injection

Experimental group

Treatment:

Drug: SHR-A1811 Injection

Treatment group B: SHR-A1811 Injection and Pertuzumab Injection

Experimental group

Treatment:

Drug: SHR-A1811 Injection ； Pertuzumab Injection

Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection

Active Comparator group

Treatment:

Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection