Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Trastuzumab

Hormones

Fulvestrant

Lapatinib

Antineoplastic Agents, Immunological

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

ARM A: Lapatinib and trastuzumab (experimental arm). Patients with hormone receptor (HR) positive breast cancer will also receive endocrine therapy at the physician's discretion (preferred choice with fulvestrant).

ARM B: Trastuzumab plus chemotherapy (control arm). Any type of chemotherapy in combination with trastuzumab will be allowed at the physician's discretion.

ARM A: oral lapatinib 1,000 mg daily in combination with intravenous trastuzumab 6mg/kg q3wks (after the initial 8 mg/kg loading dose).

Clinical Research Technology

Stefano Cascinu, MD

Simon Spazzapan, MD

Simon Spazzapan, Md

Claudio Zamagni, MD

Elisabetta Cretella, MD

Saverio Cinieri, MD

Roberto Bordonaro, MD

Michele Caruso, MD

Monica Giordano, MD

Teresa Gamucci, MD

Lucia Del Mastro, MD

Laura Scaltriti, Md

Mariangela Ciccarese, MD

Michele Gianni Turolla, MD

Michele Gianni Turolla, Md

Dino Amadori, MD

Salvatore Siena, Md

Marina Elena Cazzaniga, MD

Nando Riccardi, MD

Michele De Laurentiis, MD

Michele Orditura, MD

Grazia Arpino, MD

Vita Leonardi, MD

Anna Maria Mosconi, MD

Silvana Saracchini, MD

Claudio Dazzi, MD

Dazzi Claudio, MD

Corrado Boni, MD

Lorenzo Gianni, MD

Giuseppe Tonini, Md

Giuseppe Tonini, MD

Francesco Cognetti, Md

Cognetti Francesco, MD

Maria Luisa Barzelloni, MD

Nina Olmeo, MD

Fauso Roila, Md

Fausto Roila, MD

Mario Airoldi, MD

fabio Puglisi, MD

Fabio Puglisi, MD

Giovanni Giardina, MD

Stefania Gori, MD

Recent clinical studies have shown that the combination of lapatinib and trastuzumab has superior antitumor activity compared to either single drug in both neoadjuvant and metastatic setting and is well tolerated. According to this evidence, the combination of lapatinib and trastuzumab today offers a valid chemotherapy-free option, primarily for patients with pre-treated HER2-positive MBC

The present study is designed to determine the efficacy and safety profile of the combination of lapatinib and trastuzumab (plus endocrinetherapy in ER-positive breast cancer) versus trastuzumab and chemotherapy in heavily pretreated patient population with HER2-positive MBC and to investigate the predictive role of cfDNA for detection of HER2 gene amplification on patients' outcome. The presence of circulating free DNA (cfDNA) for detection of HER2 gene amplification was associated with worse prognosis and seems to allow early response evaluation. However, many aspects of the role of cfDNA detection in patients undergoing molecular target agents such as trastuzumab or lapatinib are not well described. With the availability of improved and standardized techniques for cfDNA detection, it should now be possible to examine several of these important questions within a prospective multicenter study and a striking potential of cfDNA for detection of HER2 gene amplification might enable a more individual and optimized antimetastatic therapy inpatients with cancer.

Safety and QoL of Trastuzumab With Lapatinib or Chemiotherapy in MBC and HER2+ Patients Refractory to Anti HER2 Therapies

A Randomised, Multicentre, Open-label Phase II Trial Investigating Activity of Chemotherapy and Lapatinib and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer (MBC) Refractory to Anti HER2 Therapies

To evaluate clinical benefit rate (CBR) for patients treated with lapatinib and trastuzumab and for patients treated with trastuzumab and chemotherapy. CBR is defined as: confirmed complete response (CR) plus partial response (PR) at any time, plus stable disease (SD) for 24 weeks

Second-line progression-free survival, defined as the time from first dosing to the first documented disease progression or death from any cause, whichever occurs first.

OS is defined as the time from first dosing in second line to death from any cause.

Safety of second line treatment will be evaluated by the frequency of AEs and SAEs, cardiac events, clinically significant abnormal laboratory tests, vital signs, and ECOG PS. All patients who received at least one dose of study treatment will be included in the safety analysis.

QoL and symptom control will be assessed using the FACT-B questionnaire.

Clinical Research Technology S.r.l.

Consorzio Oncotech

Spots Global Cancer Trial Database for anti her2 therapies