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Lapatinib+Capecitabine
Lapatinib inhibits HER2 and EGFR tyrosine kinases while capecitabine is a prodrug that converts to 5-fluorouracil to inhibit thymidylate synthase, together targeting HER2-positive breast cancer through dual mechanisms.
Lapatinib inhibits HER2 and EGFR tyrosine kinases while capecitabine is a prodrug that converts to 5-fluorouracil to inhibit thymidylate synthase, together targeting HER2-positive breast cancer through dual mechanisms. Used for HER2-positive metastatic breast cancer, HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting).
At a glance
| Generic name | Lapatinib+Capecitabine |
|---|---|
| Sponsor | Tianjin Hemay Pharmaceutical Co., Ltd |
| Drug class | Tyrosine kinase inhibitor + fluoropyrimidine chemotherapy |
| Target | HER2, EGFR (lapatinib); thymidylate synthase (capecitabine) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Lapatinib is a dual tyrosine kinase inhibitor that blocks HER2 and EGFR signaling, preventing tumor cell proliferation and survival in HER2-overexpressing cancers. Capecitabine is a fluoropyrimidine prodrug that is metabolized to 5-fluorouracil, which inhibits thymidylate synthase and disrupts DNA synthesis. The combination provides complementary cytostatic and cytotoxic effects against HER2-positive malignancies.
Approved indications
- HER2-positive metastatic breast cancer
- HER2-positive early-stage breast cancer (adjuvant/neoadjuvant setting)
Common side effects
- Diarrhea
- Hand-foot skin reaction
- Nausea
- Fatigue
- Vomiting
- Decreased appetite
- Rash
- Cardiac dysfunction (lapatinib)
Key clinical trials
- DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] (PHASE3)
- HKI-272 for HER2-Positive Breast Cancer and Brain Metastases (PHASE2)
- LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib (PHASE3)
- A Phase Ⅲ Study of Hemay022 in Combination With AI In Advanced Breast Cancer (PHASE3)
- Lapatinib and Capecitabine for Second Line Treatment of Pancreas Cancer (PHASE2)
- DETECT III - A Multicenter, Phase III Study to Compare Standard Therapy +/- Lapatinib in HER2-ve MBC-Patients With HER2+ve CTCs (PHASE3)
- A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases (PHASE2, PHASE3)
- Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lapatinib+Capecitabine CI brief — competitive landscape report
- Lapatinib+Capecitabine updates RSS · CI watch RSS
- Tianjin Hemay Pharmaceutical Co., Ltd portfolio CI