AzTrials
AzTrials

HER2-positive Breast CancerPhase 2/3NCT03085368

A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin

A Phase 2/3 study testing lapatinib/herceptin in people with HER2-positive Breast Cancer, run by Peking Union Medical College 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
lapatinib/herceptin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
482 participants
Where
1 siteChina
Study dates
1 Mar 2017to 1 Mar 2021
Phase
Phase 2/3
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 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • the first diagnosis of invasive breast cancer, confirmed by histology or cytology, and surgical resection of the primary lesions before receiving any anti breast cancer treatment;
  • female patients, aged 18 years and less than 80 years of age;
  • surgical resection of the primary tumor pathological examination, showed HER2 positive (defined as immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization (FISH) positive);
  • hormone receptor status is known, lymph node positive or sentinel lymph node negative but high risk factors
  • the eastern oncology cooperative group (ECOG) patients with physical status score was 0 -2;
  • baseline LVEF >50%
  • the relevant institutional review board (IRB) or independent ethics committee (IEC) written informed consent

Who cannot join

  • the subjects in pregnancy or lactation;
  • pregnant women may be within the first 7 days before pregnancy test positive (urine or serum).
  • received chemotherapy, endocrine or anti HER2 anti-tumor therapy;
  • congestive heart failure, unstable angina, heart failure or myocardial infarction and other diseases;
  • other invasive tumors (including the second primary breast cancer), may affect the outcome of the evaluation and program compliance; but the treatment of patients with disease free survival at least more than 5 years can be selected;
  • with chronic liver disease in patients with liver dysfunction and / or with clinical manifestations: the serum total bilirubin > 2.5 * ULN; or INR = 1.5 but no bilirubin. serum ALT or AST> * 3 * ULN; alkaline phosphatase >2.5 * ULN; ALT or AST can be gradually increased, but with gradually increasing fatigue, nausea and vomiting, fever, right upper quadrant pain or tenderness
Show all 13Show fewer
  • hematopoietic dysfunction, defined as follows: neutrophil count (ANC) <1.5 * 109/L; platelet <100 * 109/L; hemoglobin <9 g/dL;
  • other serious diseases, including: congestive heart failure (heart function NYHA grade II, III, IV) or occurred within 6 months of congestive heart failure, unstable angina, arrhythmia, myocardial infarction patients can't control or other severe cardiovascular disease; breathing at rest or need oxygen therapy; serious infection; uncontrolled diabetes;
  • there is a serious psychological or mental abnormalities, estimated that the participants to participate in this study is not strong;
  • known to study drug allergy;
  • the past 30 days participated in the study of other drug clinical trials.
  • 1, failed to complete the clinical trial of at least 1 cycles according to the program, can not carry out safety and efficacy evaluation 2, a serious violation of this research program, not in accordance with the prescribed dose, method and course of medication.
  • Patients will receive lapatinib treatment, until a predetermined end end point, or development of unacceptable toxicity, or withdrawal of consent, or illness or death, to appear before the subject.

Trial locations and contacts

1 site in 1 country.

Sun Qiang, M.D. contact

008613001289600

wangxuefei63@pumch.cn

China1 site, 1 recruiting

  • PUMCH

    Beijing, 100730

    Sun Qiang, M.D., 0086-13001289600, 1210548954@qq.com

    Wang Xuefei

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib and Paclitaxel vs Herceptin and Paclitaxel With Sequential and Synchronous Anthracycline

This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline

Read the detailed description

This is a randomized controlled trial of HER-2 positive breast cancer patients treated with lapatinib and paclitaxel vs herceptin and paclitaxel with sequential and synchronous anthracycline. Safety and efficacy are the primary endpoint. The positive expression of HER2 was confirmed by postoperative pathology in patients with breast adenocarcinoma (IDC). Patients who had not received any chemotherapy and targeted anti HER2 therapy.

In this study, the non inferiority design method, according to the wishes of patients and signed informed consent, randomly into the group, a total of 482 patients were enrolled in the trial group: the control group =1:1. The subjects were followed up for a total of 1 years, until the disease progressed, and the toxicity was not tolerated.

We want to study 84 months. The follow-up period was 5 years (the first adjuvant treatment time to the last follow-up) or the researchers decided to end the study.

Being tested
lapatinib/herceptin
Keywords
breast cancer, her-2 positive, lapatinib, herceptin
Medical subject headings
Breast Neoplasms

What participants receive

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

  • lapatinib/herceptinDrug

    Lapatinib produced by glaxosmithkline. Oral small molecule epidermal growth factor tyrosine kinase inhibitor. Mainly used for combined with capecitabine in the treatment of ErbB-2 over expression, including received prior anthracycline, paclitaxel and trastuzumab (Herceptin) in the treatment of advanced or metastatic breast cancer. Our clinical trial want to see its benefit in early breast cancer

Study groups in NCT03085368
Study groupRoleWhat they receive
EC→PL(Epirubicin+Cyclophosphamide--Docetaxel+lapatinib)ExperimentalEpirubicin 80 mg/ IV day M2 Cyclophosphamide 600 mg/m2 day IV 21 days for a total of 1 cycles, with a total of 4 cycles sequential Docetaxel 100mg/m2 IV day 1 21 days for a total of 1 cycles, with a total of 4 cycles Lapatinib 1000mg/d Po (fasting) every 30 days for a cycle Note: lapatinib in the first injection of docetaxel drug taking, once a day, oral dose of 1000mg, a total of over 1 years;
Receives: Drug: lapatinib/herceptin
PEL(Paclitaxel+epirubicin+Lapatinib)Experimental80mg/ M2 day 1 IV epirubicin Paclitaxel 150mg/m2 IV day 1 14 days for a total of 1 cycles (intensive chemotherapy), with a total of 6 cycles Also given Lapatinib 1000mg/d Po (fasting) every 30 days for a cycle Note: lapatinib in the first injection of paclitaxel drug taking, once a day, oral dose of 1000mg, a total of over 1 years;
Receives: Drug: lapatinib/herceptin
EC→PH(Epirubicin+Cyclophosphamide--Docetaxel+herceptin)Active comparatorTable 80mg/ day 1 IV Cyclophosphamide 600 mg/m2 day IV 21 days for a total of 1 cycles, with a total of 4 cycles Docetaxel 100mg/m2 IV day 1 21 days for a total of 1 cycles, with a total of 4 cycles Trastuzumab 2mg/kg IV QW (first dose 4 mg/kg) Note: trastuzumab was administered at the beginning of the first injection of paclitaxel, with an injection dose of 2mg/kg, 1 times a week, for a total of up to 1 years; followed by trastuzumab 2mg/kg IV, once every 3 weeks for a total of one year
Receives: Drug: lapatinib/herceptin
EPH(Paclitaxel+epirubicin+herceptin)Active comparator80mg/ M2 day 1 IV epirubicin Paclitaxel 150mg/m2 IV day 1 14 days for a total of 1 cycles, with a total of 6 cycles Also given Trastuzumab 2mg/kg IV QW (first dose 4 mg/kg) Note: trastuzumab was administered at the beginning of the first injection of paclitaxel, with an injection dose of 2mg/kg, 1 times a week, for a total of up to 1 years; followed by trastuzumab 2mg/kg IV, once every 3 weeks for a total of one year
Receives: Drug: lapatinib/herceptin

What is being measured

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

  1. DFS

    Since the first randomized to disease recurrence or death occurred due to other reasons, the recurrence of the disease include local, regional, distant, ipsilateral or contralateral breast cancer (excluding breast lobular carcinoma in situ) and non malignant tumor secondary breast (except the skin basal cell carcinoma or squamous cell carcinoma, cervical cancer in situ cancer).

    Measured: 3 years& 5 years

Secondary outcomes (1)

  1. OS

    0S is defined as the time from randomization to death due to any cause

    Measured: 5 years & 10 years

Timeline

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

  1. First posted21 Mar 2017
  2. Study start1 Mar 2017
  3. Primary completion1 May 2018 (estimated)
  4. Study completion1 Mar 2021 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
482 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03085368
Sponsor's protocol ID
lapatinib
Status last verified
Jul 2017
First submitted
19 Mar 2017
Last updated
28 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After obtaining the primary endpoint, we will share our IPD

Publications

  • Piccart-Gebhart M, Holmes E, Baselga J, de Azambuja E, Dueck AC, Viale G, Zujewski JA, Goldhirsch A, Armour A, Pritchard KI, McCullough AE, Dolci S, McFadden E, Holmes AP, Tonghua L, Eidtmann H, Dinh P, Di Cosimo S, Harbeck N, Tjulandin S, Im YH, Huang CS, Dieras V, Hillman DW, Wolff AC, Jackisch C, Lang I, Untch M, Smith I, Boyle F, Xu B, Gomez H, Suter T, Gelber RD, Perez EA. Adjuvant Lapatinib and Trastuzumab for Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Results From the Randomized Phase III Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization Trial. J Clin Oncol. 2016 Apr 1;34(10):1034-42. doi: 10.1200/JCO.2015.62.1797. Epub 2015 Nov 23.

    PubMed 26598744

  • Goss PE, Smith IE, O'Shaughnessy J, Ejlertsen B, Kaufmann M, Boyle F, Buzdar AU, Fumoleau P, Gradishar W, Martin M, Moy B, Piccart-Gebhart M, Pritchard KI, Lindquist D, Chavarri-Guerra Y, Aktan G, Rappold E, Williams LS, Finkelstein DM; TEACH investigators. Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: a randomised, controlled, phase 3 trial. Lancet Oncol. 2013 Jan;14(1):88-96. doi: 10.1016/S1470-2045(12)70508-9. Epub 2012 Dec 10.

    PubMed 23234763

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing lapatinib/herceptin in people with HER2-positive Breast Cancer, run by Peking Union Medical College 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 7 inclusion and 13 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 28 Jul 2017. 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 combined 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.

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?

Results are not available in the source record.

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

Contact Sun Qiang, M.D. (008613001289600, wangxuefei63@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: 3 years& 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 NCT03085368, which also lists 2 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 2017.

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

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in