Lapatinib +Capecitabine Treatment for Advanced Metastatic Breast Cancer in Women From China

NCT00508274 | Terminated Phase 3 Results

• 2 other identifiers: EGF109491CLAP016A2304
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 11

Brief Summary

Local study in China and Hong Kong to evaluate safety and efficacy in lapatinib + capecitabine in women with Human epidermal growth factor receptor 2 (HER2) positive advanced or metastatic breast cancer.

Conditions

Neoplasms, Breast

Keywords

Advanced Metastatic Breast Cancer; HER2 positive; HER2+; breast cancer; lapatinib; TYVERB; TYKERB; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate (CBR)

  CBR is defined by the percentage of participants achieving either a confirmed tumor response of complete response (CR) or partial response (PR) or stable disease (SD) for at least 24 weeks. Response Criteria in Solid Tumors (RECIST) is a system for measuring tumor shrinkage or progression in terms of the longest dimensions of the tumor on imaging scans such as computerized tomography (CT). A "partial response" requires a decrease of 30% or more, "complete response" requires all target lesions disappear, "Progression" requires an increase of at least 20%, and "Stable disease" falls in between these two. All responses have a repeat assessment to confirm the response.

  Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 90 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 90.38 months.

• Six Months Progression-Free Survival

  at Baseline and every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed up to 90.38 months, with 6 months PFS reported.

• Time to Response (TTR)

  Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 14.78 months

• Duration of Response (DOR)

  Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 88.80 months.

• Number of Participants With Central Nervous System (CNS) as First Site of Relapse

  Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was 90 months

Study Arms (1)

lapatinib in combination with capecitabine

EXPERIMENTAL

daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000mg/m2/day on days1-14 every 21 days)

Drug: lapatinib; Drug: capecitabine

Interventions

lapatinib DRUG

Lapatinib ditosylate monohydrate tablets, 250 mg, are oval, biconvex, orange, film-coated tablets taken orally.

Also known as: LAP016, GW572016

lapatinib in combination with capecitabine

capecitabine DRUG

Capecitabine is supplied as a biconvex, oblong, light peach and peach colored, film-coated tablets for oral administration.

lapatinib in combination with capecitabine

Eligibility Criteria

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

You may qualify if:

• Signed informed consent;
• Female ≥18 years;
• Pathology that has histologically confirmed invasive breast cancer with stage IIIb/c or stage IV disease;
• If recurrent disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology or histology.
• Documented overexpression of Her2 (ErbB2) of IHC 3+ or FISH positive, in primary or metastatic tumor tissue is required for enrollment into the study; by local testing or central laboratory testing determined by country of residence. NB. Approximately, 51 subjects will be enrolled in a single stage design to test for efficacy in women from China and Hong Kong. Due to the fact that trastuzumab is not commonly prescribed in China and Hong Kong, the current study allows up to 40% of subjects who are trastuzumab naïve to be enrolled.
• Prior therapies must include at minimum a taxane and/or anthracycline and may include trastuzumab if available; other prior regimens are not limited except capecitabine and Erbb2 inhibitors other than trastuzumab. Chemo regimen requirements are as follows:
• Taxane containing regimen for at least 4 cycles or \<4 cycles provided disease progression or treatment limiting toxicity occurred while on taxane
• Anthracycline containing regimen for at least 4 cycles or \<4 cycles provided disease progression or treatment limiting toxicity occurred while on anthracycline
• Taxanes and Anthracyclines may have been administered concurrently or separately
• Prior treatment may have contained trastuzumab alone or in combination with other chemotherapy in the adjuvant, locally advanced or metastatic setting and patient must have failed the treatment
• Prior treatment with capecitabine is not permitted unless 6 months have elapsed since the last dose of capecitabine and the subject is free of any capecitabine related toxicity
• Prior therapy with an ErbB1 and/or ErbB2 inhibitor, other than trastuzumab is not permitted
• Other prior chemo-regimens not listed above are unlimited.
• For those subjects whose disease is ER+ and/or PR+ one of following criteria should be met.
• Subjects who received hormonal therapy and are no longer benefiting from this therapy and the hormonal treatment must have been stopped before the first dose of investigational treatment

You may not qualify if:

• Pregnant or lactating females at anytime during the study
• Subjects with only non-measurable metastatic sites of disease per RECIST, (e.g. bone metastases, pleural effusion, or ascites, etc.);
• Planned concurrent anti-cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy) while taking investigational treatment;
• Unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment;
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
• History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma, are eligible;
• Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety;
• Uncontrolled infection;
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (11)

Novartis Investigative Site

Guangzhou, Guangdong, 510060, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510515, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430030, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210009, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310006, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310022, China

Location

Novartis Investigative Site

Beijing, 100021, China

Location

Novartis Investigative Site

Beijing, 100071, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Hong Kong, Hong Kong

Location

Novartis Investigative Site

Shatin, Hong Kong

Location

Related Publications (1)

• Xu BH, Jiang ZF, Chua D, Shao ZM, Luo RC, Wang XJ, Liu DG, Yeo W, Yu SY, Newstat B, Preston A, Martin AM, Chi HD, Wang L. Lapatinib plus capecitabine in treating HER2-positive advanced breast cancer: efficacy, safety, and biomarker results from Chinese patients. Chin J Cancer. 2011 May;30(5):327-35. doi: 10.5732/cjc.010.10507.

  PMID: 21527065 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Lapatinib; Capecitabine

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Data collection post 1-Jul-2019 was not reportable due to local regulations in China.

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: July 18, 2007
• Primary Completion: December 2, 2015
• Study Completion: July 1, 2020
• Last Updated: September 21, 2021
• Results First Posted: September 3, 2009

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

HK (2); CN (9)