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

NCT03085368 | Unknown Phase 2 DMC

• 1 other identifier: lapatinib
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HER2-positive Breast Cancer

Keywords

breast cancer; her-2 positive; lapatinib; herceptin

Outcome Measures

Primary Outcomes (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).

  3 years& 5 years

Secondary Outcomes (1)

• OS

  5 years & 10 years

Other Outcomes (1)

• biomarker

  5 years

Study Arms (4)

EC→PL(Epirubicin+Cyclophosphamide--Docetaxel+lapatinib)

EXPERIMENTAL

Epirubicin 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;

Drug: lapatinib/herceptin

PEL(Paclitaxel+epirubicin+Lapatinib)

EXPERIMENTAL

80mg/ 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;

Drug: lapatinib/herceptin

EC→PH(Epirubicin+Cyclophosphamide--Docetaxel+herceptin)

ACTIVE COMPARATOR

Table 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

Drug: lapatinib/herceptin

EPH(Paclitaxel+epirubicin+herceptin)

ACTIVE COMPARATOR

80mg/ 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

Drug: lapatinib/herceptin

Interventions

lapatinib/herceptin DRUG

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

EC→PH(Epirubicin+Cyclophosphamide--Docetaxel+herceptin); EC→PL(Epirubicin+Cyclophosphamide--Docetaxel+lapatinib); EPH(Paclitaxel+epirubicin+herceptin); PEL(Paclitaxel+epirubicin+Lapatinib)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• , 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Taizhou EOC Pharma Co., Ltd.: collaborator

Study Sites (1)

PUMCH

Beijing, 100730, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 26598744 RESULT

• 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.

  PMID: 23234763 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Sun Qiang, M.D.

  PUMCH

  STUDY CHAIR

Central Study Contacts

Sun Qiang, M.D.

CONTACT

008613001289600; wangxuefei63@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2017
• First Posted: March 21, 2017
• Study Start: March 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: March 1, 2021
• Last Updated: July 28, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)