HER2-Positive Breast CancerPhase 2neoCARHNCT03140553
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer
A Phase 2 study testing TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) in people with HER2-Positive Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-Positive Breast Cancer
- What is being tested?
- TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 11 Nov 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed HER2 positive invasive breast carcinoma
- Clinical stage Ⅱ-ⅢC
- Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
- Signed informed consent
- Adequate organ function within 2 weeks of study entry:
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- Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3 Total bilirubin < upper limit of normal Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility
- Patients must be over 18 years old.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.
Who cannot join
- Metastatic disease
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
- History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TCH (Docetaxel/Carboplatin/Trastuzumab) Versus EC -TH(Epirubicin/Cyclophosphamide Followed by Docetaxe/Trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer
Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment in HER2-Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
- Conditions
- HER2-Positive Breast Cancer
- Being tested
- TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)
- Keywords
- Neoadjuvant Treatment, HER2-Positive Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)Drug
TCH (docetaxel/carboplatin/trastuzumab) versus EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer
| Study group | Role | What they receive |
|---|---|---|
| TCH | Experimental | docetaxel/carboplatin/trastuzumab Receives: Drug: TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) |
| EC-TH | Active comparator | epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab Receives: Drug: TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
pathologic complete response
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Sep 2016
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HER2-Positive Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KunWang, Guangdong Provincial People's Hospital
- Investigators
- Kun Wang, MD, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140553
- Sponsor's protocol ID
- 20170308
- Acronym
- neoCARH
- Status last verified
- Jul 2020
- First submitted
- 2 May 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang C, Li P, Chen Y, Zheng J, Zhang X, Gao HF, Zhang L, Wang K. Pooled analysis of NeoCARH and NeoCART trials: patient-reported outcomes in patients with early-stage breast cancer receiving platinum-based or anthracycline-based neoadjuvant chemotherapy. Support Care Cancer. 2024 Jun 3;32(6):401. doi: 10.1007/s00520-024-08610-3.
PubMed 38829506Gao HF, Wu Z, Lin Y, Song XY, Cao Y, Chen QJ, Zhang G, Fu P, Liu Z, Zhang LL, Yang CQ, Yang M, Zhu T, Ji F, Li JQ, Cheng MY, Wang K. Anthracycline-containing versus carboplatin-containing neoadjuvant chemotherapy in combination with trastuzumab for HER2-positive breast cancer: the neoCARH phase II randomized clinical trial. Ther Adv Med Oncol. 2021 Apr 20;13:17588359211009003. doi: 10.1177/17588359211009003. eCollection 2021.
PubMed 33959195Li WP, Zhu T, Hu MX, Yang M, Ji F, Gao HF, Yang CQ, Zhang LL, Cheng MY, Xu FP, Wang K. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer. Neoplasma. 2020 Nov;67(6):1409-1415. doi: 10.4149/neo_2020_200130N96. Epub 2020 Jul 13.
PubMed 32657611
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCH (Docetaxel/Carboplatin/Trastuzumab) Versus EC -TH(Epirubicin/Cyclophosphamide Followed by Docetaxe/Trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT03140553
- Acronym / sponsor ID
- neoCARH / 20170308
- Conditions
- HER2-Positive Breast Cancer
- Keywords
- Neoadjuvant Treatment, HER2-Positive Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 4 May 2017 (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.
Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment in HER2-Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCH | Experimental | Drug: TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)docetaxel/carboplatin/trastuzumab |
| EC-TH | Active comparator | Drug: TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed HER2 positive invasive breast carcinoma
- Clinical stage Ⅱ-ⅢC
- Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
- Signed informed consent
Key exclusion criteria (3 listed)
- Metastatic disease
- Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
- History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
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 |
|---|---|---|
| TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)TCH (docetaxel/carboplatin/trastuzumab) versus EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer | Drug | EC-TH, TCH |
Primary outcome
pCR
Time frame: one year
pathologic complete response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Derived from this study: PubMed 38829506Yang C, Li P, Chen Y, Zheng J, Zhang X, Gao HF, Zhang L, Wang K. Pooled analysis of NeoCARH and NeoCART trials: patient-reported outcomes in patients with early-stage breast cancer receiving platinum-based or anthracycline-based neoadjuvant chemotherapy. Support Care Cancer. 2024 Jun 3;32(6):401. doi: 10.1007/s00520-024-08610-3.
- Derived from this study: PubMed 33959195Gao HF, Wu Z, Lin Y, Song XY, Cao Y, Chen QJ, Zhang G, Fu P, Liu Z, Zhang LL, Yang CQ, Yang M, Zhu T, Ji F, Li JQ, Cheng MY, Wang K. Anthracycline-containing versus carboplatin-containing neoadjuvant chemotherapy in combination with trastuzumab for HER2-positive breast cancer: the neoCARH phase II randomized clinical trial. Ther Adv Med Oncol. 2021 Apr 20;13:17588359211009003. doi: 10.1177/17588359211009003. eCollection 2021.
- Derived from this study: PubMed 32657611Li WP, Zhu T, Hu MX, Yang M, Ji F, Gao HF, Yang CQ, Zhang LL, Cheng MY, Xu FP, Wang K. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer. Neoplasma. 2020 Nov;67(6):1409-1415. doi: 10.4149/neo_2020_200130N96. Epub 2020 Jul 13.
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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.
Kun Wang, MD principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) in people with HER2-Positive Breast Cancer, run by Guangdong Provincial People's 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 3 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: finished, as of the sponsor's last update on 28 Jul 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pCR (time frame: one year). 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 NCT03140553, which also lists 3 linked publications.
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 28 Jul 2020.