Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Trastuzumab

Hormones

Exemestane

Letrozole

Anastrozole

Aromatase Inhibitors

Lapatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Tyrosine

lapatinib

Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks

trastuzumab

Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily

Aromatase inhibitor

Novartis Pharmaceuticals

A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).

This was a Phase III, randomized, open-label, multi-center, three arm study of lapatinib plus trastuzumab plus an aromatase inhibitor (AI), trastuzumab plus an AI, or lapatinib plus an AI to evaluate the efficacy and safety of these regimens as first- or second-line therapy in postmenopausal subjects with hormone receptor positive (HR+), HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies. Eligible subjects was postmenopausal; had tumors that are ER and/or PgR positive and HER2-positive; had Stage IV metastatic breast cancer. The primary objective was to demonstrate superiority of lapatinib/trastuzumab/AI combination versus (vs.) trastuzumab/AI combination for progression free survival. The secondary objectives were to evaluate progression free survival in trastuzumab/AI vs. lapatinib/AI and trastuzumab/lapatinib/AI vs. lapatinib/AI, overall survival, overall response rate, clinical benefit rate, the safety and tolerability of all three treatment groups (lapatinib plus trastuzumab plus an AI, trastuzumab plus an AI, or lapatinib plus an AI), and quality of life status relative to baseline.

A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer

A Phase III Trial to Compare the Safety and Efficacy of Lapatinib Plus Trastuzumab Plus an Aromatase Inhibitor (AI) vs. Trastuzumab Plus an AI vs. Lapatinib Plus an AI as 1st- or 2nd- Line Therapy in Postmenopausal Subjects With Hormone Receptor+, HER2-positive Metastatic Breast Cancer (MBC) Who Received Prior Trastuzumab and Endocrine Therapies

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Progression free survival (PFS) of lapatinib/trastuzumab/aromatase inhibitor (AI) combination vs. trastuzumab/AI combination. PFS is defined as the time from randomization to the earliest date of disease progression (with radiological evidence) or death from any cause, or to the date of censor.

PFS in the lapatinib arm vs. the trastuzumab arm and in the lapatinib+trastuzumab arm vs. the lapatinib arm.

OS was defined as the interval of time (in weeks) between the date of randomization and the date of death due to any cause. For subjects who did not die during the study, death was censored at the date of last contact.

The best overall response was the best response recorded from the start of the treatment until disease progression/recurrence \& was determined programmatically using investigators assessment of responses of target lesion, non-target lesion and new lesions based on RECIST v1.1. CR=disappearance of all target lesion \& non-target lesions, if applicable, and no new lesion; PR = ≥30% decrease in the sum of the longest diameter of target lesions \& non-target lesion was neither non-CR nor progressive disease (Non-PD) or not evaluable (NE); stable disease (SD) = Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD (SD should maintain for at least 56 days); PD = ≥20% increase from nadir (smallest sum diameters recorded since treatment start) of the target lesions and/or any status for non-target lesions or appearance of new lesion; NE = cannot be classified by the above definitions. Overall Response (OR) = CR + PR.

Clinical Benefit Rate (CBR) was defined as the percentage of patients with evidence of complete response (CR) or partial response (PR) at any time or maintaining SD for at least 24 weeks while on study, according to the investigator assessment of response per RECIST 1.1 criteria.

Kaplan-Meier estimates for duration of response in lapatinib+trastuzumab+AI vs. trastuzumab+AI and lapatinib+AI vs. trastuzumab+AI. Duration of response is defined as the time from first documented Complete Response or Partial Response until the first documented sign of Progressive Disease or Death, or to the date of censor.

Quality of life was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. It is a 37-item (27 general questions and 10 breast cancer specific questions) self-reporting instrument consisting of 5 dimensions: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and a breast cancer subscale (BCS). The followings are the score ranges for each self-reporting subscale: • PWB : 0-28 • SWB : 0-28 • EWB : 0-24 • FWB : 0-28 • BCS : 0-40 FACT-B Total Outcome Index (TOI) = PWB + FWB + BCS (range:0 - 96) FACT-B Total Score = PWB + SWB + EWB + FWB + BCS (range:0-148) FACT-G Total Score = PWB + SWB + EWB + FWB (range:0-108) In the scoring system, negative stated items are reversed by subtracting the response from "4" and after reversing proper items, all subscale items are summed to a total, which is the subscale score. For all the FACIT scales and symptom indices, the higher the score the better cut off

Time to response in lapatinib+trastuzumab+AI vs. trastuzumab+AI and lapatinib+AI vs. trastuzumab+AI. Time to response is defined as time from randomization to first documented Complete Response or Partial Response.

GlaxoSmithKline

The assessment was done in the safety population which included 353 subjects. Two subjects randomized to trastuzumab did not receive any study treatment and were therefore excluded from the safety population.

lapatinib (1000mg) plus trastuzumab (6mg/kg) plus an AI (Aromatase Inhibitors)

Lapatinib+Trastuzumab+Al

Lapatinib (1500mg) plus AI (Aromatase Inhibitors)

Lapatinib+AI

Trastuzumab (6 mg/kg) +AI (Aromatase Inhibitors)

Trastuzumab+AI

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Intent-to-Treat (ITT) population comprised all randomized subjects regardless of whether or not treatment was administered. ITT was based on the treatment to which the subject was randomized and was the primary population for the analysis of efficacy data. Any subject who received a treatment randomization # was considered to have been randomized.

Study Director

Null hypothesis H0: λ ≥ 1 or to reject it in favor of the alternative hypothesis HA: λ \<1, where λ is the hazard ratio (HR) between Treatment Group A and Treatment Group B for progression-free survival.

Disease progression or died (event)

Censored, follow-up for disease progression ended

Censored, f/p for disease progression ongoing

PFS of Lapatinib+Trastuzumab+AI Combination vs. Trastuzumab+AI Combination

Censored, follow-up ended

Censored, follow-up ongoing

PFS of Trastuzumab/AI vs. Lapatinib/AI and Trastuzumab/Lapatinib/AI vs. Lapatinib/AI

Death

Overall Survival (OS) Events of Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI

Overall Response Rate (ORR; Complete or Partial Response) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI

Clinical Benefit Rate (CBR; Complete Response, Partial Response, or Stable Disease for at Least 6 Months) in Lapatinib+Trastuzumab+AI vs. Trastuzumab+AI and Lapatinib+AI vs. Trastuzumab+AI

Spots Global Cancer Trial Database for 1st line mbc

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