AzTrials
AzTrials

HER2 Positive Early Breast CancerPhase 3NCT05883852

EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer

A Phase 3 study testing Docetaxel, carboplatin and Trastuzumab in people with HER2 Positive Early Breast Cancer, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
HER2 Positive Early Breast Cancer
What is being tested?
Docetaxel, carboplatin and Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,406 participants
Where
1 siteChina
Study dates
7 Jun 2023to 1 Jul 2031
Phase
Phase 3
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；
  • 0-1 for ECOG；
  • Unilateral invasive carcinoma confirmed by histology (regardless of pathological type)；
  • No gross or microscopic tumor remains after surgical resection；
  • Early breast cancer, pathologically confirmed as HER2 positive; HER2 positive definition: Immunohistochemical HER2 3+ or FISH/CISH test positive (with amplification) is defined as HER2 positive；
  • Postoperative pathological stage pT1-4N1-3M0；
Show all 14Show fewer
  • Did not receive neoadjuvant chemotherapy in the past；
  • The longest period from surgery to randomization was not more than 8 weeks, and no adjuvant therapy had been received after surgery；
  • No peripheral neuropathy；
  • Good postoperative recovery, at least 1 week interval between operation；
  • The major organs function normally, that is, meet the following criteria: (1) The standard of blood routine examination shall meet: HB ≥90 g/L (no blood transfusion within 14 days); ANC ≥1.5×109 /L; PLT ≥100×109 /L; (2) Biochemical examination should meet the following standards: TBIL ≤1.5×ULN (upper limit of normal value); ALT and AST ≤3 x ULN; Serum Cr ≤1.5×ULN；
  • Contraception during treatment for women of reproductive age；
  • Cardiac function: LVEF>50% for ultrasound examination；
  • The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up。

Who cannot join

  • Bilateral breast cancer or carcinoma in situ DCIS/LCIS；
  • Have received chemotherapy for advanced disease；
  • Transfer of any part；
  • If any tumor >T4a (accompanied by skin invasion, mass adhesion fixation, inflammatory breast cancer)；
  • Patients with clinical or imaging suspicion of malignancy on the opposite breast but not confirmed, requiring biopsy；
  • Have received neoadjuvant therapy, including chemotherapy, radiotherapy and endocrine therapy；
Show all 17Show fewer
  • Malignant neoplasms (other than basal cell carcinoma of the skin and carcinoma in situ of the cervix), including contralateral breast cancer, within the previous 5 years；
  • The patient has been enrolled in other clinical trials；
  • Patients with severe systemic disease and/or uncontrolled infection were unable to be enrolled in the study；
  • LVEF<50% (cardiac ultrasound)；
  • Severe cardiovascular and cerebrovascular disease (e.g., unstable angina, chronic heart failure, uncontrolled hypertension >150/90mmgh, myocardial infarction or cerebrovascular accident) within 6 months prior to randomization；
  • Known allergy to related drugs；
  • Women of childbearing age refuse contraception during treatment and within 8 weeks after completion of treatment；
  • Pregnant and lactating women；
  • Those who tested positive for pregnancy before taking the drug after joining the trial；
  • Mental illness, cognitive impairment, inability to understand the trial protocol and side effects, inability to complete the trial protocol and follow-up workers ；(systematic evaluation is required before trial enrollment)；
  • Persons without personal freedom and independent capacity for civil conduct。

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center Shanghai, China, 200032

    Shanghai, Shanghai Municipality, 200032

    Zhimin Shao, M.D., +86-021-64175590 ext. 88807, zhimingshao@yahoo.com

    Linxiaoxi Ma, M.D, +86-021-64175590 ext. 63169, mary2008white@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled, Phase III Trial in HER2-positive Lymph Node Positive Early Breast Cancer to Compare the Efficacy and Safety of Epriubin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Pertuzumab (EC-THP) Versus Docetaxel and Carboplatin Plus Trastuzumab and Pertuzumab (TCbHP) in the Adjuvant Treatment

compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients

Read the detailed description

The objective of this study is to conduct a randomized controlled clinical study to compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients, so as to further optimize adjuvant chemotherapy regimen for breast cancer.

Being tested
Docetaxel, carboplatin, Trastuzumab, Pertuzumab, Epirubicin

What participants receive

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

  • DocetaxelDrug

    Docetaxel is a taxoid antineoplastic agent used in the treatment of breast cancer

  • carboplatinDrug

    Carboplatin is a DNA synthesis inhibitor which binds to DNA, inhibits replication and transcription and induces cell death.

  • TrastuzumabDrug

    Trastuzumab is a humanized monoclonal antibody derived from recombinant DNA,

  • PertuzumabDrug

    Pertuzumab is a recombinant humanized monoclonal antibody that specifically binds to the extracellular dimerization domain (subdomain Ⅱ) of epidermal growth factor receptor 2(HER2).

  • EpirubicinDrug

    Epirubicin is an antineoplastic agent derived from doxorubicin.Epirubicin, like doxorubicin, exerts its antitumor effects by interference with the synthesis and function of DNA and is most active during the S phase of the cell cycle.

  • cyclophosphamideDrug

    An anticancer (antitumor or cytotoxic) chemotherapy drug that is classified as an alkylating agent. Alkylating agents are compounds that prevent the normal connection of the double helix chain by adding an alkyl group to the guanine base of the DNA molecule. It causes breaks in DNA strands, affecting the ability of cancer cells to proliferate.

Study groups in NCT05883852
Study groupRoleWhat they receive
Arm A：TCbHPExperimentalDocetaxel 75mg/m2 ivgtt d1+ carboplatin AUC=6 ivgtt d1+ trastuzumab first dose 8mg/kg (maintain 6mg/kg) d1 ivgtt d1+ Pertuzumab first dose 840mg (maintain 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
Receives: Drug: Docetaxel; Drug: carboplatin; Drug: Trastuzumab; Drug: Pertuzumab
Arm B：EC-THPActive comparatorEpirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 3 weeks of treatment, a total of 4 courses; Docetaxel 100mg/m2 ivgtt d1+ trastuzumab first dose 8mg/kg (maintenance 6mg/kg) d1 ivgtt d1+ pertuzumab first dose 840mg (maintenance 420mg) ivgtt d1, 3 weeks of treatment, a total of 6 courses. After the completion of chemotherapy, the dual-target therapy was continued for one year.
Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Epirubicin; Drug: cyclophosphamide

What is being measured

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

  1. iDFS

    invasive Disease Free Survival

    Measured: 5 years

Secondary outcomes (3)

  1. DRFS

    distant relapse free survival

    Measured: 5 years

  2. OS

    overall survival

    Measured: 5 years

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Incidence of treatment-emergent adverse events adverse events according to CTCAE 5.0

    Measured: 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 posted1 Jun 2023
  2. Study start7 Jun 2023
  3. Primary completion1 Jul 2031 (estimated)
  4. Study completion1 Jul 2031 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,406 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05883852
Sponsor's protocol ID
SCHBCC-N055
Status last verified
Jun 2023
First submitted
20 May 2023
Last updated
27 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel, carboplatin and Trastuzumab in people with HER2 Positive Early Breast Cancer, run by Fudan University 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 14 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 27 Jun 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

iDFS (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 NCT05883852.

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 27 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in