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HER2-positive Breast CancerPhase 2SHERONCT04158856

Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer

A Phase 2 study testing Pyrotinib and Trastuzumab in people with HER2-positive Breast Cancer, run by xuexin he.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
Pyrotinib and Trastuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
1 Jun 2020to 31 May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged 18-70 years old
  • Have finished radical operation
  • Histologically confirmed invasive ductal carcinoma (IDCA)
  • According to AJCC ,pT<8mm, pN0, no evidence for metastasis
  • Operation specimens are available for ER, progesterone receptor (PR) and HER2 detection, patients should be HER2 positive tumor (IHC staining of 3+ [uniform, intense membrane staining of >30% of invasive tumor cells], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio [HER2 gene signals to chromosome 17 signals] of >2.2), nuclear grade 3.
  • Should have tumor tissue available and sufficient for multi-spots sampling.
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  • It has been <84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician.
  • Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1, expected survival time > 12 months
  • Cardiac function had to be within normal limits (left ventricular ejection fraction [LVEF] ≥50%), as established by multiple gated acquisition scan or echocardiography.
  • Adequate bone marrow function, adequate liver and renal function, and adequate coagulation function.
  • Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
  • Written informed consent according to the local ethics committee requirements.

Who cannot join

  • pT≥8mm or node positive
  • Metastatic breast cancer
  • Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
  • With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
  • Patients with medical conditions that indicate intolerant to adjuvant target therapy and related treatment, including severe infection, coagulation disorder, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
  • Has symptomatic peripheral neuropathy > grade 2 according to NCI
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  • Known severe allergy to any drugs in this study
  • Has cardiac dysfunction or lung dysfunction defined as follows:
  • grade ≥3 CHF according to NCI CTCAE v 5.0 or NYHA≥II
  • angina which requires drug control, cardiac infraction, and any other vascular disease with apparent clinical symptoms
  • uncontrolled high-risk arrhythmia
  • uncontrolled hypertension
  • Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
  • Patient is pregnant or breast feeding

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xuexin He, MD contact

+86-18329139569

xuexinhe@zju.edu.cn

About this study

Official title: Adjuvant Dual Anti-HER2 Therapy in Patients With Tumors < 8mm, Node-negative, HER2-positive Breast Cancer :a Single-group Arm, Open-label, Prospective, Phase 2 Study

This phase II trial aims to study the efficacy and safety of adjuvant Pyrotinib plus trastuzumab in patients with tumors <8mm, node-negative, HER2-positive breast cancer.

Being tested
Pyrotinib, Trastuzumab

What participants receive

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

  • PyrotinibDrug

    Also called Pyrotinib Maleate Tablets

    400mg po every day

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days

Study groups in NCT04158856
Study groupRoleWhat they receive
Experimental ArmExperimentaladjuvant Pyrotinib plus Trastuzumab
Receives: Drug: Pyrotinib; Drug: Trastuzumab

What is being measured

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

  1. Disease-free Survival

    stimated percentage of patients alive and disease-free at 5 years from randomization or censored at date of last follow-up.

    Measured: 5 years

Secondary outcomes (4)

  1. Breast Cancer Specific Survival

    Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer specific survival is defined as the time from randomization to death from breast cancer relapse; or censored at date last known alive.

    Measured: 5 years

  2. Overall Survival

    Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.

    Measured: 5 years

  3. Treatment-related adverse events

    Incidence and severity of adverse events as assessed by NCI CTCAE V5.0

    Measured: up to 3 months

  4. Change of LVEF after treatment

    The change of LVEF after 3 months treatment compared to the baseline LVEF

    Measured: up to 3 months

Timeline

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

  1. First posted12 Nov 2019
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion31 May 2023 (estimated)
  4. Study completion31 May 2030 (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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04158856
Sponsor's protocol ID
SHERO
Acronym
SHERO
Status last verified
Nov 2019
First submitted
7 Nov 2019
Last updated
12 Nov 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib and Trastuzumab in people with HER2-positive Breast Cancer, run by xuexin he.

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 12 inclusion and 14 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: opening soon, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Xuexin He, MD (+86-18329139569, xuexinhe@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: 5 years). 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 NCT04158856.

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 12 Nov 2019.

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