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Breast CancerPhase 2NCT05726175

Disitamab Vedotin(RC48) Combined With Penpulimab(AK105) for Neoadjuvant Treatment of HER2-low Breast Cancer

A Phase 2 study testing Disitamab Vedotin and Penpulimab in people with Breast Cancer, run by West China Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Disitamab Vedotin and Penpulimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Mar 2023to 31 Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Female patients aged 18 to 70 years who were newly treated;
  • ECOG systemic state 0~1;
  • The predicted survival time was no less than 3 months
  • According to the RECIST 1.1 , at least one measurable lesion exists;
  • Patients with HER2-low breast cancer confirmed by pathological examination, clinical stage II-III [cT1N1,cT2 and any N, cT3 and any N; cT4 and any N, according to American Joint Committee on Cancer (AJCC) standards];
  • The functional level of organs must meet the following requirements: (1) Blood routine: 1) ANC >= 1.5x10^9/L; 2) PLT >= 90x10^9/L; 3) Hb >= 90 g/L; (2) Blood biochemistry: 1) TBIL <= 1.5 ULN; 2) ALT and AST <= 2 ULN; 3) BUN and Cr 1.5 ULN and creatinine clearance 50 mL/min (Cockcroft-Gault formula); (3) Heart color Doppler ultrasound: LVEF >= 50%; (4) 12-lead ECG: Fridericia corrected QT interval (QTcF) female < 470 ms.
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  • Known the hormone receptor status;
  • Tissue samples were available for biomarker testing
  • The serum pregnancy test is negative and patients with reproductive potential must agree to use effective non-hormonal contraceptive methods during treatment and at least 6 months after the last use of the test drug;
  • Volunteer to join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

Who cannot join

  • Patients with inflammatory breast cancer.
  • Patients with metastatic breast cancer (stage IV)
  • Received any anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, surgical treatment (major surgery for breast cancer), endocrine therapy or molecular targeted therapy, immunotherapy, biological therapy, etc.
  • Participated in other drug clinical trials within 4 weeks before enrollment.
  • Have received a live vaccine within 4 weeks before the start of the study dose or plan to receive any vaccine during the study;
  • Previous or current use of HER2-targeted monoclonal antibodies (trastuzumab, pertuzumab, etc.), tyrosine kinase inhibitors (lapatinib, pyrrootinib, lenatinib, etc.), ADC drugs (RC48, T-DM1, DS8201a, etc.).
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  • Prior treatment with anti-PD-1, PD-L1, or PD-L2 or another agent that acts directly on a T-cell surface inhibitory receptor (e.g., CTLA-4, OX-40, CD137).
  • Other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma.
  • Concomitant receipt of any other antineoplastic therapy.
  • Presence of third-space effusion (including massive pleural effusion or ascites) that cannot be controlled by drainage or other methods.
  • Known hypersensitivity or delayed hypersensitivity reactions to the drugs of this regimen, its components or similar drugs;
  • Have an active autoimmune disease requiring systemic treatment (e.g., disease modulating medication, corticosteroids, or immunosuppressive medication) in the past 2 years;
  • Receiving systemic steroid therapy (at a daily dose of more than 10 mg prednisone equivalent) or any form of immunosuppressive therapy within 7 days before the diagnosis of immunodeficiency or the first dose of study treatment;
  • Known history of active pulmonary tuberculosis (tuberculosis, Mycobacterium tuberculosis);
  • Have a history of immunodeficiency, including testing positive for HIV, or other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
  • Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus DNA copy number ≥2000 IU/mL (HBsag-positive and hepatitis B virus DNA copy number <2000 IU/mL patients should receive anti-HBV treatment for at least 2 weeks before the first dose); He was positive for hepatitis C virus (HCV) antibody and HCV RNA test
  • History of pneumonia (noninfectious) requiring steroid therapy or current pneumonia.
  • Have had any history of cardiac disease, including: (1) angina pectoris; (2) medically treatable or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) any other cardiac diseases that were judged by the investigators to be unsuitable for the trial.
  • Pregnant, lactating women, fertile women with a positive baseline pregnancy test, or women of childbearing age who were unwilling to use effective contraception throughout the trial.
  • Concomitant diseases (including but not limited to uncontrolled hypertension, severe diabetes, active infection, etc.) that, in the judgment of the investigator, seriously endanger the safety of the patient or prevent the patient from completing the study.
  • Prior history of a defined neurological or psychiatric disorder, including epilepsy or dementia.
  • The patient was considered by the investigator to be ineligible for any other circumstances in the study.

Trial locations and contacts

1 site in 1 country.

Ting Luo, post-doctor contact

18602866299

tina621@163.com

China1 site

  • West China Hospital, Sichuan University

    Chengdu, Chengdu, Sichuan, China, 610041

Other trials in China

About this study

Official title: A Single-arm, Single-center Exploratory Clinical Study of Disitamab Vedotin Combined With Penpulimab as Neoadjuvant Therapy in the Treatment of HER2-low Early or Locally Advanced Breast Cancer

To evaluate the efficacy and safety of Disitamab Vedotin combined with Penpulimab as neoadjuvant therapy in patients with HER2-low early or locally advanced breast cancer

Read the detailed description

Subjects who met the criteria for admission were treated with Disitamab Vedotin（2.0mg/kg,iv,q3w） combined with Penpulimab (200mg,iv,q3w) as neoadjuvant therapy for 6 cycles before surgery, and DCR and ORR were assessed before surgery. All subjects who are suitable for surgery undergo surgery and evaluate their pCR rate (pathological complete remission rate). The postoperative treatment plan was developed according to the subjects' condition and willingness。

Conditions
Breast Cancer
Being tested
Disitamab Vedotin, Penpulimab
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Disitamab VedotinDrug

    Also called RC48

    Disitamab Vedotin(RC48)：2.0mg/kg, iv, day1, q3weeks, 6 cycles in total;

  • PenpulimabDrug

    Also called AK105

    Penpulimab(AK105)：200mg, iv, day1, q3weeks, 6 cycles in total;

Study groups in NCT05726175
Study groupRoleWhat they receive
RC48 and AK105ExperimentalDisitamab Vedotin(RC48) combined with Penpulimab(AK105) as neoadjuvant therapy
Receives: Drug: Disitamab Vedotin; Drug: Penpulimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response rate (pCR) (ypT0/is N0)

    No microscopically detectable remnants of aggressive tumors in breast and axillary lymph nodes, ductal carcinoma in situ is allowed.

    Measured: Immediately after surgery

Secondary outcomes (4)

  1. Objective response rate (ORR)

    The percentage of subjects with CR or PR as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of preoperative neoadjuvant therapy (CR+PR)/Analysis of the total number of people.The solid tumor response assessment standard (RECIST 1.1 standard) was used to assess the objective tumor response.

    Measured: Baseline (Before surgery)

  2. Disease Control Rate (DCR)

    The percentage of patients with complete remission (CR), partial remission (PR) and stable disease (SD) (≥4 weeks) confirmed by the RECIST 1.1 standard among patients with evaluable efficacy.

    Measured: Baseline (Before surgery)

  3. Complete remission rate of breast pathology (bpCR)

    No microscopically detectable remnants of aggressive tumors in breast, ductal carcinoma in situ is allowed

    Measured: Immediately after surgery

  4. Adverse events (AEs)

    AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE)version 5.0. The type, grade and frequency of AEs will be reported.

    Measured: From screening phase through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start1 Mar 2023 (estimated)
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Aug 2024 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05726175
Sponsor's protocol ID
RCVDBCIIR005
Status last verified
Feb 2023
First submitted
30 Jan 2023
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Disitamab Vedotin and Penpulimab in people with Breast Cancer, run by West China Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ting Luo, post-doctor (18602866299, tina621@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (pCR) (ypT0/is N0) (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05726175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.

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