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HER2-Positive Breast CancerPhase 2NCT04094896

TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer

A Phase 2 study testing TCHP in people with HER2-Positive Breast Cancer, run by Guangdong Provincial People's 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HER2-Positive Breast Cancer
What is being tested?
TCHP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
17 Sep 2019to 17 Sep 2022
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

  • • Histologically or cytologically confirmed HER2 positive invasive breast carcinoma
  • Clinical stage #-#B
  • Patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
  • 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
Show all 11Show fewer
  • Adequate organ function within 2 weeks of study entry:
  • 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.

Kung Wang, MD contact

: 00862083827812 ext. 50910

gzwangkun@126.com

China1 site, 1 recruiting

  • Guangdong General Hospital

    Guangzhou

    Kun Wang, MD, 00862083827812 ext. 50910, gzwangkun@126.com

    Recruiting

Other trials in China

About this study

Official title: TCHP (Docetaxel/Carboplatin/Trastuzumab/Pertuzumab) Versus EC -THP(Epirubicin/ Cyclophosphamide Followed by Docetaxe/Trastuzumab/Pertuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer

This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)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.

Read the detailed description

Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)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 ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)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.

Being tested
TCHP
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.

  • TCHPDrug

    Also called TCHP vs EC-THP

    Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)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 ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)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 groups in NCT04094896
Study groupRoleWhat they receive
Arm A: TCHPExperimentaldocetaxel/carboplatin/trastuzumab/Pertuzumab
Receives: Drug: TCHP
Arm B: EC-THPActive comparatorepirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab
Receives: Drug: TCHP

What is being measured

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

  1. 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.

  1. First posted19 Sep 2019
  2. Study start17 Sep 2019
  3. Primary completion17 Sep 2022 (estimated)
  4. Study completion17 Sep 2022 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04094896
Sponsor's protocol ID
2018396H
Status last verified
Sep 2019
First submitted
17 Sep 2019
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TCHP 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 11 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: status not confirmed, as of the sponsor's last update on 19 Sep 2019. 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 Kung Wang, MD (: 00862083827812 ext. 50910, gzwangkun@126.com), or a site near the patient. 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 NCT04094896.

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 19 Sep 2019.

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