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

HER2-positive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03085368
• Other study ID #: lapatinib
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 19, 2017
• Last updated: July 26, 2017
• Start date: March 1, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: July 2017
• Source: Peking Union Medical College Hospital
• Contact: Sun Qiang, M.D.
• Phone: 008613001289600
• Email: wangxuefei63[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 482
• Est. completion date: March 1, 2021
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. 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;

2. female patients, aged 18 years and less than 80 years of age;

3. surgical resection of the primary tumor pathological examination, showed HER2 positive (defined as immunohistochemistry [IHC] 3+ or fluorescence in situ hybridization (FISH) positive);

4. hormone receptor status is known, lymph node positive or sentinel lymph node negative but high risk factors

5. the eastern oncology cooperative group (ECOG) patients with physical status score was 0 -2;

6. baseline LVEF >50%

7. the relevant institutional review board (IRB) or independent ethics committee (IEC) written informed consent

Exclusion Criteria:

1. the subjects in pregnancy or lactation;

2. pregnant women may be within the first 7 days before pregnancy test positive (urine or serum).

3. received chemotherapy, endocrine or anti HER2 anti-tumor therapy;

4. congestive heart failure, unstable angina, heart failure or myocardial infarction and other diseases;

5. 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;

6. 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

7. hematopoietic dysfunction, defined as follows: neutrophil count (ANC) <1.5 * 109/L; platelet <100 * 109/L; hemoglobin <9 g/dL;

8. 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;

9. there is a serious psychological or mental abnormalities, estimated that the participants to participate in this study is not strong;

10. known to study drug allergy;

11. 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• lapatinib/herceptin
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

Locations

Country	Name	City	State
China	PUMCH	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	EddingPharm Oncology Co., LTD.

Country where clinical trial is conducted

China, 

References & Publications (2)

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 investigator — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	biomarker	A retrospective study was performed to examine the correlation between the prognosis of the two adjuvant and biomarkers, including but not limited to Ki67, PI3K, C-MYC, IGF1R, P95HER2, P53 and other biomarkers	5 years
Primary	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	OS	0S is defined as the time from randomization to death due to any cause	5 years & 10 years