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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06057610
• Collaborator: (none)
• Enrollment: 864
• Arms: 3
• Anticipated Duration (Months): 108

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HER2-PositiveRecurrent or Metastatic Breast Cancer	Drug: SHR-A1811 Injection; Drug: SHR-A1811 Injection ； Pertuzumab Injection; Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 864 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
• Anticipated Study Start Date: Oct 1, 2023
• Anticipated Primary Completion Date: Oct 1, 2027
• Anticipated Study Completion Date: Oct 1, 2032

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group A: SHR-A1811 Injection	Drug: SHR-A1811 Injection; SHR-A1811 Injection
Experimental: Treatment group B: SHR-A1811 Injection and Pertuzumab Injection	Drug: SHR-A1811 Injection ； Pertuzumab Injection; SHR-A1811 Injection ； Pertuzumab Injection
Active Comparator: Treatment group C: Trastuzumab Injection, Pertuzumab Injection and Docetaxel Injection	Drug: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection; Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival by Blinded Independent Central Review [from first dose to disease progression, or death, whichever comes first, up to 3 years]

Secondary Outcome Measures

1. Progression Free Survival by investigators [from first dose to disease progression, or death, whichever comes first, up to 3 years]

2. Overall Survival [from first dose to death, up to 6 years]

3. Objective Response Rate [from first dose to disease progression or death, whichever comes first, up to 3 years]

4. Duration of response [from first dose to disease progression or death, whichever comes first, up to 3 years]

5. AE [from Day1 to 40 or 90 days after last dose]

6. Incidence and severity of serious adverse events (SAE) [from Day1 to 40 or 90 days after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06057610
• Other Study ID Numbers: SHR-A1811-307
• First Posted: Sep 28, 2023
• Last Update Posted: Sep 28, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Docetaxel; Trastuzumab; Pertuzumab

Study Results

No Results Posted as of Sep 28, 2023