HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant TherapyPhase 3NCT06126640
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
A Phase 3 study testing SHR-A1811 and Trastuzumab Emtansine in people with HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial summary
This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy，This study will examine SHR-A1811versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
- What is being tested?
- SHR-A1811 and Trastuzumab Emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,615 participants
- Where
- 2 sitesChina
- Study dates
- 20 Nov 2023to Apr 2032
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is 18-75 years old (including both ends), and female
- HER2 positive invasive breast cancer Confirmed by pathological examination
- Clinical Stage before Neoadjuvant Therapy was T1-4, N0-3, M0 (excluding T1N0).
- Residual invasive cancer confirmed by pathological examination after radical surgery must meet one of the following two conditions:
- If the clinical stage before neoadjuvant therapy is cT4N0-3M0 or cT1-3N2-3M0, there is residual invasive cancer in the primary breast lesion and/or ipsilateral axillary lymph nodes after surgery.
- If the clinical stage before neoadjuvant therapy was cT1-3N0-1M0 (except T1N0), there was residual invasive cancer in the ipsilateral axillary lymph nodes after surgery.
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- Previous neoadjuvant therapy must meet all of the following conditions:
- Neoadjuvant chemotherapy: At least 6 treatment cycles, including no less than 9 weeks of taxane-based chemotherapy (anthracycline-containing chemotherapy allowed).
- Neoadjuvant anti-HER2 targeted therapy: No less than 9 weeks of targeted therapy including trastuzumab must be completed.
- Have received radical surgery for breast cancer:
- The interval from the completion of radical surgery to the first random medication should be at least 3 weeks and no more than 12 weeks.
- Hormone receptor (HR) status was confirmed by postoperative pathologic examination. HR positive is defined as positive for the estrogen receptor (ER) or progesterone receptor (PR), and HR negative is defined as negative for both ER and PR.
- The ECOG score is 0 or 1
- Heart function is good
- Agree to birth control
Who cannot join
- Stage IV metastatic breast cancer
- Evidence of recurrent breast cancer, including local recurrence, regional recurrence and distant metastasis .
- In the past 5 years, patients suffered from other malignant tumors, excluding cured basal cell carcinoma of skin andcervical carcinoma in situ,.
- Previously received systemic anti-HER2-ADC drug therapy, including but not limited to trastuzumab emtansine (T-DM1), Trastuzumab Deruxtecan (T-DXd), etc.
- Previous dosage requirements for anthracycline exposure meet one of the following conditions:
- Doxorubicin or anthracyclines with similar exposure equivalent > 240mg/m2;
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- Epirubicin or liposomal doxorubicin hydrochloride > 480mg/m2.
- History of cardiovascular diseases with clinical significance, such as severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA ≥ Ⅱ), supraventricular or ventricular arrhythmia with clinical significance and requiring treatment or intervention, and myocardial infarction within 6 months.
- Subjects with known or suspected interstitial pneumonia.
- Known hereditary or acquired bleeding and thrombosis tendency.
- History of active hepatitis B, hepatitis C or liver cirrhosis.
- There were other serious physical or mental diseases or abnormal laboratory examinations that may increase the risk of participating in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Phase III, Multicenter, Randomized, Open-Label, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy，This study will examine SHR-A1811versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes after neoadjuvant therapy.The primary objective is to compare invasive disease-free survival (IDFS) between SHR-A1811 and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS), overall survival (OS) and distant recurrence-free interval (DRFI).
- Being tested
- SHR-A1811, Trastuzumab Emtansine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
Lyophilized powder injection, 100mg / bottle, intravenous drip
Trastuzumab EmtansineDrug
Lyophilized powder injection, 160mg / bottle, 100mg / bottle, intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| SHR-A1811 | Experimental | Not described Receives: Drug: SHR-A1811 |
| Trastuzumab Emtansine (T-DM1) | Active comparator | Not described Receives: Drug: Trastuzumab Emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease-free survival (IDFS)
Measured: Randomization until the disease progressed, up to approximately 77 months postdose
Secondary outcomes (4)
Disease-free survival (DFS)
Measured: Randomization until the disease progressed, up to approximately 77 months postdose
Overall survival(OS)
Measured: Randomization until death from any cause, up to approximately 101 months postdose.
Distant recurrence-free interval (DRFI)
Measured: Randomization until distant recurrence or death from any cause, up to approximately 101 months postdose.
Safety endpointPercentage of Adverse Events in Participants
Measured: Baseline up to approximately 101 months postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start20 Nov 2023
- Primary completionApr 2030 (estimated)
- Study completionApr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant TherapyStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,615 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126640
- Sponsor's protocol ID
- SHR-A1811-305
- Status last verified
- Jun 2026
- First submitted
- 7 Nov 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided