A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
Recruiting
Phase 3
Interventional Study
Early-stage or Locally Advanced HER2-positive Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 740 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
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About This Trial
This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoad…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Females treated for the first time, 18-75 years old;
2. ECOG score 0-1;
3. Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
4. Results of laboratory tests meet the enrollment requirements;
5. Pregnancy test result must be negative and must agree to…
Contacts