Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bone Density Conservation Agents

Capecitabine

Tamoxifen

Exemestane

Letrozole

Anastrozole

Toremifene

Antimetabolites

Pyrotinib: 400mg QD Po for half a year, and Capecitabine: 500mg Tid Po for half a year Use of endocrine drugs in endocrine receptor (HR)-positive patients after chemotherapy. For premenopausal patients: tamoxifen (10 mg po, bid, for 5 years) or toremifene (60 mg po, qd, for 5 years); for postmenopausal patients: letrozole (2.5 mg, po, qd for 5 years) or anastrozole (1 mg, po, qd for 5 years) or exemestane (25 mg, po, qd for 5 years).

After chemotherapy, radiation therapy will be started if necessary.

No adjuvant chemotherapy or targeted therapy. Use of endocrine drugs in endocrine receptor (HR)-positive patients after chemotherapy. For premenopausal patients: tamoxifen (10 mg po, bid, for 5 years) or toremifene (60 mg po, qd, for 5 years); for postmenopausal patients: letrozole (2.5 mg, po, qd for 5 years) or anastrozole (1 mg, po, qd for 5 years) or exemestane (25 mg, po, qd for 5 years).

After chemotherapy, radiation therapy will be started if necessary.

Pyrotinib and Capecitabine for half a year

Capecitabine，Pyrotinib

Zhimin Shao, MD

Zhi-Ming Shao, MD

Ruoxi Wang, MD

Ying Zhou

For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive. The APT study enrolled patients with stage I HER2-positive breast cancer and has confirmed the efficacy and safety of intravenous chemotherapy combined with targeted therapy, but only 2.2% of the patients enrolled in microinvasion are enrolled, and there is a lack of large sample size data to provide a treatment reference for these patients. In order to further explore the optimal strategy for adjuvant therapy in this type of patient, we designed a new clinical trial to evaluate the efficacy and safety of oral capecitabine plus pyrotinib as adjuvant therapy in previous retrospective studies.

Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer

Fudan University

Director of General Surgery of Fudan Shanghai Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer	NCT05861271	Breast Cancer S...	Capecitabine，Py...	18 Years - 70 Years	Fudan University
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer	NCT05861271	Breast Cancer S...	Capecitabine，Py...	18 Years - 70 Years	Fudan University

Spots Global Cancer Trial Database for capecitabine，pyrotinib