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

September 21, 2023 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

864

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival by Blinded Independent Central Review
Time Frame: from first dose to disease progression, or death, whichever comes first, up to 3 years
from first dose to disease progression, or death, whichever comes first, up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival by investigators
Time Frame: from first dose to disease progression, or death, whichever comes first, up to 3 years
from first dose to disease progression, or death, whichever comes first, up to 3 years
Overall Survival
Time Frame: from first dose to death, up to 6 years
from first dose to death, up to 6 years
Objective Response Rate
Time Frame: from first dose to disease progression or death, whichever comes first, up to 3 years
from first dose to disease progression or death, whichever comes first, up to 3 years
Duration of response
Time Frame: from first dose to disease progression or death, whichever comes first, up to 3 years
from first dose to disease progression or death, whichever comes first, up to 3 years
AE
Time Frame: from Day1 to 40 or 90 days after last dose
from Day1 to 40 or 90 days after last dose
Incidence and severity of serious adverse events (SAE)
Time Frame: from Day1 to 40 or 90 days after last dose
from Day1 to 40 or 90 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2032

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-A1811-307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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