Breast CancerPhase 3NCT05474690
A Study Comparing the Efficacy of TCbHP and ECHP-THP in the Neoadjuvant Treatment of HER2-positive Breast Cancer
A Phase 3 study testing Docetaxel + Carboplatin + Trastuzumab + Pertuzumab and (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab) in people with Breast Cancer and HER2-positive Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
In 2020, the incidence of breast cancer surpassed that of lung cancer for the first time, becoming the number one cancer in the world. HER2 is an important prognostic indicator and therapeutic target for breast cancer. HER2-overexpressing breast cancer accounts for about 20% to 30% of all breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Docetaxel + Carboplatin + Trastuzumab + Pertuzumab and (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2022to 30 Aug 2024
- Phase
- Phase 3
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years ≤ age ≤ 65 years, Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1；
- Clinical T2-T4d, or T1c with axillary LN+；
- HER2 + invasive breast cancer confirmed by histopathology Note: HER2 expression positive refers to the tumor cells with immunohistochemical staining intensity of 3 + or confirmed positive by fluorescence in situ hybridization [fish] at least once during the pathological detection/review of primary tumor in the Department of pathology of participating research center hospital；
- Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum target or MR (optional) within 1 month before randomization
- Organ and bone marrow function test within one month before chemotherapy showed no chemotherapy contraindication： Absolute value of neutrophil count ≥ 2.0×10^9 / L Hemoglobin ≥ 100g / L Platelet count ≥ 100×10^9 / L Total bilirubin < 1.5 ULN (upper limit of normal value) Creatinine < 1.5 × ULN AST/ALT < 1.5×ULN
- Echocardiography: left ventricular ejection fraction (LVEF ≥ 55%)；
- For women of childbearing age, serum pregnancy test was negative 14 days ；
- Signed the informed consent form prior to patient entry；
Who cannot join
- Stage IV (metastatic) breast cancer;
- supraclavicular lymph node metastasis；
- For this disease, chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- The patient has undergone major surgical procedures not related to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
- The patient has severe heart disease or discomfort, including but not limited to the following:Diagnosed history of heart failure or systolic dysfunction (LVEF < 50%)；High-risk uncontrolled arrhythmias；Angina pectoris requiring antianginal medication；Clinically significant heart valve disease；ECG showing transmural myocardial infarction；Poorly controlled high blood pressure；
- Because the patient has other serious and uncontrollable medical diseases, the investigator believes that chemotherapy is contraindicated;
- Known history of allergy to the drug components of this regimen; history of immunodeficiency, including HIV positive test, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Non-inferior, Randomized Controlled Phase III Clinical Study Comparing the Efficacy of TCbHPand ECHP-THP in Neoadjuvant Treatment of Operable HER2-positive Breast Cancer
In 2020, the incidence of breast cancer surpassed that of lung cancer for the first time, becoming the number one cancer in the world. HER2 is an important prognostic indicator and therapeutic target for breast cancer. HER2-overexpressing breast cancer accounts for about 20% to 30% of all breast cancer patients. Targeted therapy for HER2 protein is the core treatment for this type of breast cancer. At present, the neoadjuvant treatment mode of trastuzumab and pertuzumab dual-target chemotherapy has become the standard neoadjuvant treatment for high-risk HER2-positive breast cancer. For patients with early-stage high-risk or locally advanced HER2-positive breast cancer, whether standard neoadjuvant regimen without anthracycline can achieve the same therapeutic effect compared with regimen containing anthracycline is still inconclusive.Therefore, this study aimed to compare the efficacy and safety of two neoadjuvant treatment regimens, TCbHP*6 and ECHP*4-THP*4, in the neoadjuvant treatment of HER2-positive breast cancer through a randomized controlled phase 3 clinical trial.
Read the detailed description
Subjects were screened according to inclusion and exclusion criteria. Subjects who met the inclusion conditions were randomly divided into TCbHP group and ECHP-THP group according to 1:1.
Stratified at randomization by the following factors: T, N, HER2 expression (HER2 protein 3+ vs HER2 protein 2+ but FISH+), and hormone receptor status (HR positive vs HR negative).
- Drug dose of TCbHP regimen: docetaxel 75 mg/m2 + carboplatin (AUC=6) + trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg) + Pascal Tocilizumab (initial loading dose of 840 mg, followed by maintenance dose of 420 mg), every 21 days as a cycle.
- Dosage of ECHP-THP regimen: epirubicin 90mg/m2 + cyclophosphamide 600mg/m2 followed by docetaxel 90mg/m2, trastuzumab (the first loading dose of 8 mg/kg, followed by maintenance The dose is 6 mg/kg) + Pertuzumab (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Docetaxel + Carboplatin + Trastuzumab + Pertuzumab, (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)
- Keywords
- Breast cancer, HER2, pathological complete remission
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel + Carboplatin + Trastuzumab + PertuzumabDrug
Also called TCbHP regimen group
Subjects who met the inclusion conditions were randomly divided into TCbHP group and ECHP-THP group according to 1:1.
Stratified at randomization by the following factors: T, N, HER2 expression (HER2 protein 3+ vs HER2 protein 2+ but FISH+), and hormone receptor status (HR positive vs HR negative).
TCbHP regimen drug dose: docetaxel 75 mg/m2 + carboplatin (AUC=6) + trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg) + pertuzumab Antibiotics (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.
(Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)Drug
Also called ECHP-THP regimen group
Dosage of ECHP-THP regimen: epirubicin 90mg/m2+cyclophosphamide 600mg/m2 followed by docetaxel 90mg/m2, trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg /kg) + Pertuzumab (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.
| Study group | Role | What they receive |
|---|---|---|
| TCbHP chemotherapy regimen | Active comparator | Docetaxel + Carboplatin + Trastuzumab + Pertuzumab Receives: Drug: Docetaxel + Carboplatin + Trastuzumab + Pertuzumab |
| ECHP-THP chemotherapy regimen | Experimental | (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab) Receives: Drug: (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
Percentage of Participants With Pathological Complete Response (pCR) (ypT0/is/N0M0) after 6 cycles of neoadjuvant chemotherapy
Measured: up to 24 weeks
Secondary outcomes (5)
Number of treatment-related adverse events assessed by CTCAE v4.0
Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Measured: up to 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Dose adjustment rate and withdrawal rate of chemotherapy drugs in two chemotherapy regimens
Measured: up to 24 weeks
ORR
Objective response rate.ORR assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1)
Measured: up to 24 weeks
DFS
From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Measured: up to 60 months
OS
From date of surgery to death from any cause，whichever came first
Measured: up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start11 May 2022
- Primary completion28 Mar 2023
- Study completion30 Aug 2024 (estimated)
Why it stopped: The new treatment plan for HER2 positive breast cancer has entered the diagnosis and treatment guide. The treatment plan ECHP-THP in this study is not the optimal treatment plan, therefore this study was terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474690
- Sponsor's protocol ID
- HNCH-BC010
- Status last verified
- Feb 2024
- First submitted
- 17 May 2022
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-inferior, Randomized Controlled Phase III Clinical Study Comparing the Efficacy of TCbHPand ECHP-THP in Neoadjuvant Treatment of Operable HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT05474690
- Acronym / sponsor ID
- HNCH-BC010
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Keywords
- Breast cancer, HER2, pathological complete remission
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The new treatment plan for HER2 positive breast cancer has entered the diagnosis and treatment guide. The treatment plan ECHP-THP in this study is not the optimal treatment plan, therefore this study was terminated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 11 May 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In 2020, the incidence of breast cancer surpassed that of lung cancer for the first time, becoming the number one cancer in the world. HER2 is an important prognostic indicator and therapeutic target for breast cancer. HER2-overexpressing breast cancer accounts for about 20% to 30% of all breast cancer patients. Targeted therapy for HER2 protein is the core treatment for this type of breast cancer. At present, the neoadjuvant treatment mode of trastuzumab and pertuzumab dual-target chemotherapy has become the standard neoadjuvant treatment for high-risk HER2-positive breast cancer. For patients with early-stage high-risk or locally advanced HER2-positive breast cancer, whether standard neoadjuvant regimen without anthracycline can achieve the same therapeutic effect compared with regimen containing anthracycline is still inconclusive.Therefore, this study aimed to compare the efficacy and safety of two neoadjuvant treatment regimens, TCbHP*6 and ECHP*4-THP*4, in the neoadjuvant treatment of HER2-positive breast cancer through a randomized controlled phase 3 clinical trial.
Detailed description
Subjects were screened according to inclusion and exclusion criteria. Subjects who met the inclusion conditions were randomly divided into TCbHP group and ECHP-THP group according to 1:1.
Stratified at randomization by the following factors: T, N, HER2 expression (HER2 protein 3+ vs HER2 protein 2+ but FISH+), and hormone receptor status (HR positive vs HR negative).
- Drug dose of TCbHP regimen: docetaxel 75 mg/m2 + carboplatin (AUC=6) + trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg) + Pascal Tocilizumab (initial loading dose of 840 mg, followed by maintenance dose of 420 mg), every 21 days as a cycle.
- Dosage of ECHP-THP regimen: epirubicin 90mg/m2 + cyclophosphamide 600mg/m2 followed by docetaxel 90mg/m2, trastuzumab (the first loading dose of 8 mg/kg, followed by maintenance The dose is 6 mg/kg) + Pertuzumab (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCbHP chemotherapy regimen | Active comparator | Drug: Docetaxel + Carboplatin + Trastuzumab + PertuzumabDocetaxel + Carboplatin + Trastuzumab + Pertuzumab |
| ECHP-THP chemotherapy regimen | Experimental | Drug: (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)(Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years ≤ age ≤ 65 years, Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1；
- Clinical T2-T4d, or T1c with axillary LN+；
- HER2 + invasive breast cancer confirmed by histopathology Note: HER2 expression positive refers to the tumor cells with immunohistochemical staining intensity of 3 + or confirmed positive by fluorescence in situ hybridization [fish] at least once during the pathological detection/review of primary tumor in the Department of pathology of participating research center hospital；
- Clinically measurable lesions: measurable lesions revealed by ultrasound, molybdenum target or MR (optional) within 1 month before randomization
- Organ and bone marrow function test within one month before chemotherapy showed no chemotherapy contraindication： Absolute value of neutrophil count ≥ 2.0×10^9 / L Hemoglobin ≥ 100g / L Platelet count ≥ 100×10^9 / L Total bilirubin < 1.5 ULN (upper limit of normal value) Creatinine < 1.5 × ULN AST/ALT < 1.5×ULN
Key exclusion criteria (8 listed)
- Stage IV (metastatic) breast cancer;
- supraclavicular lymph node metastasis；
- For this disease, chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. have been received;
- The patient has a second primary malignancy other than adequately treated skin cancer;
- The patient has undergone major surgical procedures not related to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel + Carboplatin + Trastuzumab + PertuzumabAlso: TCbHP regimen groupSubjects who met the inclusion conditions were randomly divided into TCbHP group and ECHP-THP group according to 1:1. Stratified at randomization by the following factors: T, N, HER2 expression (HER2 protein 3+ vs HER2 protein 2+ but FISH+), and hormone receptor status (HR positive vs HR negative). TCbHP regimen drug dose: docetaxel 75 mg/m2 + carboplatin (AUC=6) + trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg/kg) + pertuzumab Antibiotics (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle. | Drug | TCbHP chemotherapy regimen |
| (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab)Also: ECHP-THP regimen groupDosage of ECHP-THP regimen: epirubicin 90mg/m2+cyclophosphamide 600mg/m2 followed by docetaxel 90mg/m2, trastuzumab (first loading dose 8 mg/kg, sequential maintenance dose 6 mg /kg) + Pertuzumab (the initial loading dose of 840 mg, and the sequential maintenance dose of 420 mg), every 21 days as a cycle. | Drug | ECHP-THP chemotherapy regimen |
Primary outcome
Pathological Complete Response (pCR)
Time frame: up to 24 weeks
Percentage of Participants With Pathological Complete Response (pCR) (ypT0/is/N0M0) after 6 cycles of neoadjuvant chemotherapy
5 secondary outcomes
Number of treatment-related adverse events assessed by CTCAE v4.0
Time frame: up to 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 24 weeks
ORR
Time frame: up to 24 weeks
DFS
Time frame: up to 60 months
OS
Time frame: up to 120 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenzhen Liu principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel + Carboplatin + Trastuzumab + Pertuzumab and (Epirubicin + Cyclophosphamide - Docetaxel) + (Trastuzumab + Pertuzumab) in people with Breast Cancer and HER2-positive Breast Cancer, run by Henan Cancer 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 8 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Feb 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2024.