ClinicalTrials.gg
Sign In
Status unknownNCT05353361Updated Sep 15, 2023

A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer

A Phase 2 interventional study of SHR-A1811：Pyrotinib and SHR-A1811；Pertuzumab in Breast Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Status unknown at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-09-15.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
402
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.

02

Conditions studied

  • Breast Cancer

Browse trials for

03

In context

Breast Neoplasms

12,820 studies on the registry are indexed under Breast Neoplasms; 2,923 are open to participants now.

This study's planned enrollment of 402 is above the median of 72 across 9,498 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 571 studies on the registry; 86 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Women aged 18 to 75 (inclusive)
  2. 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

Exclusion Criteria:

  1. Have other malignancies within the past 5 years
  2. Active central nervous system metastasis without surgery or radiotherapy
  3. Presence with uncontrollable third space effusion
  4. Have undergone other anti-tumor treatment within 4 weeks before the first dose
  5. Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
  6. Any active autoimmune disease or a history of autoimmune disease
  7. A history of immune deficiency
  8. Clinically significant cardiovascular disorders
  9. Clinically significant history of lung disease
  10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
  11. Known hereditary or acquired bleeding tendency
  12. Active hepatitis and liver cirrhosis
  13. Presence of other serious physical or mental diseases or laboratory abnormalities
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
402 participants (estimated)

Study arms

  • Experimental
    SHR-A1811combined Pyrotinib

    Drug: SHR-A1811：Pyrotinib

  • Experimental
    SHR-A1811Combined Pertuzumab

    Drug: SHR-A1811；Pertuzumab

  • Experimental
    SHR-A1811Combined Adebrelimab

    Drug: SHR-A1811；Adebrelimab

  • Experimental
    SHR-A1811Combined Albumin-bound Paclitaxel

    Drug: SHR-A1811；Albumin paclitaxel

Interventions

  • DrugSHR-A1811：Pyrotinib

    SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib：Tablet, 160mg / tablet, 80mg / tablet, oral

  • DrugSHR-A1811；Pertuzumab

    SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab：Injection, 420 Mg (14 ml) / bottle, intravenous drip

  • DrugSHR-A1811；Adebrelimab

    SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab：Injection, 12ml: 0.6g/bottle, intravenous drip

  • DrugSHR-A1811；Albumin paclitaxel

    SHR-A1811：Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel：Injection, 100mg / box, intravenous drip

06

What researchers measure

Primary outcomes

  1. DLT（Phase I (dose exploration phase) ）

    Time frame: 21 days after the first administration of each subject

  2. AE（Phase I (dose exploration phase) ）

    Time frame: from Day1 to 40 or 90 days after last dose

  3. Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ）

    Time frame: from Day1 to 40 or 90 days after last dose

  4. Objective response rate（Phase II (efficacy expansion phase)）

    Time frame: Two years after the last subject was enrolled in the group

Secondary outcomes

  1. PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  2. PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  3. PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  4. PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  5. PK parameter: C4h of Pyrotinib（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  6. PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  7. Immunogenicity of SHR-A1811（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  8. Immunogenicity of Adebrelimab（Phase I secondary endpoint）

    Time frame: through study completion, an average of 2 years

  9. Objective Response Rate（Phase I secondary endpoint）

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  10. Duration of response（Phase I secondary endpoint）

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  11. Progression Free Survival（Phase I secondary endpoint）

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  12. AE（Phase II secondary study endpoint）

    Time frame: from Day1 to 40 or 90 days after last dose

  13. Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint）

    Time frame: from Day1 to 40 or 90 days after last dose

  14. PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811（Phase II secondary study endpoint）

    Time frame: through study completion, an average of 2 years

  15. PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint）

    Time frame: through study completion, an average of 2 years

  16. PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint）

    Time frame: through study completion, an average of 2 years

  17. Immunogenicity of SHR-A1811（Phase II secondary study endpoint）

    Time frame: through study completion, an average of 2 years

  18. Immunogenicity of Adebrelimab（Phase II secondary study endpoint）

    Time frame: through study completion, an average of 2 years

  19. Duration of response（Phase II secondary study endpoint）

    Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years

  20. Progression Free Survival（Phase II secondary study endpoint）

    Time frame: from first dose to disease progression, or death, whichever comes first, up to 3 years

  21. Event-Free Survival Rate（Phase II secondary study endpoint）

    Time frame: from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years

07

Study locations

1 of 1 sites recruiting
  • Jiangsu Provincial People's Hospital
    Nanjing, Jiangsu 210029, China
    • Yongmei Yin · Principal investigator
    • Jinhai Tang · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2022 (actual). Primary completion is estimated for Dec 2025, 43 months after the start.

Of 218 industry-sponsored phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 55. This study's planned 43 months is above that.

Counting every sponsor, half of 1,201 studies reached it within 49 months; a quarter within 31 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 19, 2022
First posted
Apr 29, 2022
StartActual
May 23, 2022
Primary completionEst.
Dec 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Sep 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05353361
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 29, 2022
Start date
May 23, 2022
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 15, 2023

Study contacts

Xiaoxue Pi
Contact
Xiaoxue.pi@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms →

Other studies from this sponsor

Jiangsu HengRui Medicine Co., Ltd. →

Start the discussion