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Kadcyla Medical Research Studies

Up-to-date List of Kadcyla Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Kadcyla Medical Research Studies

Rank Status Study
1 Recruiting A Phase 1b Study of ONT-380 Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer
Condition: HER2 Positive Breast Cancers
Interventions: Drug: ONT-380;   Drug: T-DM1
Outcome Measures: Incidence and severity of adverse events;   incidence and severity of clinical lab abnormalities;   anti-tumor activity of ONT-380 given at the MTD/RD in combination with T-DM1
2 Recruiting BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx
Conditions: HER2-positive Breast Cancer;   Recurrent Breast Cancer;   Stage IIIA Breast Cancer;   Stage IIIB Breast Cancer;   Stage IIIC Breast Cancer;   Stage IV Breast Cancer
Interventions: Drug: PI3K inhibitor BYL719;   Biological: ado-trastuzumab emtansine;   Other: pharmacological study;   Other: laboratory biomarker analysis
Outcome Measures: Determine the Dose Limiting Toxicity (DLT) of dose-escalating BYL719 in combination with T-DM1;   Determine the Maximum Tolerated Dose (MTD) of BYL719 in combination with T-DM1;   Blood will be collected to determine how the body responds to study drugs;   Progression-Free Survival (PFS);   Objective Response Rate (ORR)
3 Recruiting A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Patients With HER2-Positive Metastatic Breast Cancer and Patients With HER2-Positive Locally Advanced / Metastatic Gastric Cancer
Condition: Breast Cancer, Gastric Cancer
Interventions: Drug: capecitabine;   Drug: trastuzumab emtansine [Kadcyla]
Outcome Measures: Phase I: Maximum tolerated dose (MTD) of the combination of Kadcyla and capecitabine in metastatic breast cancer;   Phase II: Overall response rate (ORR) in metastatic breast cancer, based on best overall response (BOR) rate according to RECIST v.1.1;   Phase I: Maximum tolerated dose (MTD) of the combination of Kadcyla and capecitabine in metastatic gastric cancer;   Phase I - Pharmacokinetics: Serum concentration of trastuzumab emtansine;   Phase I - Pharmacokinetics: Serum concentration of trastuzumab;   Phase I - Pharmacokinetics: Plasma concentration of DM1;   Phase I - Pharmacokinetics: Plasma concentration of capecitabine;   Phase I - Pharmacokinetics: Plasma concentration of 5-fluorouracil;   Phase I - Safety: incidence of adverse events of the combination of Kadcyla and capecitabine;   Phase II: ORR in metastatic gastric cancer, based on BOR rate according to RECIST v.1.1;   Phase II: Time to response according to RECIST;   Phase II: Duration of response according to RECIST;   Phase II: Time to progression according to RECIST;   Phase II: Time to treatment failure according to RECIST;   Phase II: Progression free survival according to RECIST;   Phase II: Clinical benefit rate according to RECIST;   Phase II: Overall survival according to RECIST;   Phase II - Safety: incidence of adverse events
4 Recruiting T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
Conditions: HER-2 Positive Breast Cancer;   Breast Cancer;   Stage II Breast Cancer;   Stage III Breast Cancer
Interventions: Drug: T-DM1;   Drug: Pertuzumab;   Procedure: Excision of tumor/mastectomy
Outcome Measures: Pathologic complete response (pCR);   Intratumor heterogeneity of HER2 amplification;   Clinical response;   Safety and tolerability of T-DM1 plus pertuzumab assessed by incidence of adverse events which will be reported by term and by maximum grade using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0;   Enrichment for HER2-negativity or HER2 heterogeneity in residual tumors treated with T-DM1 plus pertuzumab preoperative therapy;   Disease-free and overall survival in patient groups defined by HER2 heterogeneity who are treated with T-DM1 plus pertuzumab
5 Recruiting Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Conditions: Bone Metastases;   HER2-positive Breast Cancer;   Liver Metastases;   Lung Metastases;   Recurrent Breast Cancer;   Soft Tissue Metastases;   Stage IV Breast Cancer
Interventions: Radiation: fludeoxyglucose F 18;   Procedure: positron emission tomography;   Procedure: computed tomography;   Biological: trastuzumab;   Radiation: copper Cu 64-DOTA-trastuzumab;   Biological: ado-trastuzumab emtansine;   Other: laboratory biomarker analysis
Outcome Measures: Tumor uptake of copper Cu 64-DOTA-trastuzumab as measured by PET;   Metabolic tumor response to ado-trastuzumab emtansine as assessed by fludeoxyglucose F 18 PET/CT;   Copper Cu 64-DOTA-trastuzumab uptake metrics;   Presence of putative MMRs to ado-trastuzumab emtansine
6 Recruiting A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Trastuzumab Emtansine (T-DM1) With or Without Standard Endocrine Therapy vs. Trastuzumab With Standard Endocrine Therapy Given for Twelve Weeks in Patients With Operable HER2+/HR+ Breast Cancer Within the ADAPT Protocol.
Condition: Breast Cancer
Interventions: Drug: T-DM1;   Drug: Trastuzumab
Outcome Measures: Comparison of the pCR rates in patients with HER2+/HR+ breast cancer treated by preoperative T-DM1 with or without standard endocrine therapy or trastuzumab with endocrine therapy.;   Evaluation of dynamic testing (based on proliferation/apoptosis changes in serial biopsy and imaging by MRI) after three weeks of treatment as a surrogate parameter for response.;   Evaluation of dynamic test regarding prediction of 5-year event-free survival (EFS);   Overall survival;   Toxicity/cardiac safety;   Overall safety in the three treatment arms;   Health-related quality of life (HRQL)
7 Recruiting Ado-Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery
Conditions: HER2-positive Breast Cancer;   Recurrent Breast Cancer;   Stage IIIB Breast Cancer;   Stage IIIC Breast Cancer;   Stage IV Breast Cancer
Interventions: Biological: ado-trastuzumab emtansine;   Other: laboratory biomarker analysis;   Other: pharmacological study
Outcome Measures: Thrombokinetic changes;   Platelet function, measured using a bleeding time test;   Incidence, type, and severity of adverse events (AEs) graded according to the NCI CTCAE v4.0;   Incidence, type, and severity of serious AEs graded according to the NCI CTCAE v4.0;   Incidence of AEs leading to study treatment discontinuation, modification, or interruption, graded according to the NCI CTCAE v4.0;   Incidence of abnormal laboratory values;   LVEF;   Death;   Cause of death;   Objective response rate, based on investigator assessment using RECIST v. 1.1;   PFS assessed using RECIST v. 1.1;   Duration of objective response, based on investigator assessment using RECIST v.1.1;   Clinical benefit rate, defined as the proportion of patients who achieve an objective response (complete response or partial response), or maintain stable disease for at least 6 months from study entry, based on investigator assessment using RECIST v 1.1
8 Recruiting T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)
Condition: Breast Cancer
Interventions: Drug: Trastuzumab;   Drug: Paclitaxel;   Drug: Trastuzumab emtansine
Outcome Measures: Disease Free Survival in Patients Treated with T-DM1;   Disease Free Survival in Patient Groups Defined by Tumor Size;   Percentage of participants with Grade 3-4 Cardiac Dysfunction;   Percentage of participants with T-DM1 Induced Grade 2-4 Thrombocytopenia;   Percentage of Patients with Amenorrhea at specific time points;   Overall Survival in Patients Treated with T-DM1
9 Recruiting A Dose-Escalation Study Evaluating the Combination of Trastuzumab Emtansine (T-DM1) With Neratinib in Women With Metastatic HER2-Positive Breast Cancer
Condition: Breast Cancer
Interventions: Drug: Neratinib;   Drug: T-DM1
Outcome Measures: Safety and tolerability of T-DM1 and neratinib to determine the recommended Phase II dose (RP2D);   Overall response rate (ORR) by measurement of target lesions;   Progression-free survival (PFS) time from start of study therapy to disease progression;   Objective tumor decrease and stable disease (SD) measurement of target lesions;   Adverse events experienced by participants as a measure of toxicity;   Molecular and genetic profiles of tumor samples collected.;   Pharmacokinetic interactions;   Therapeutic drug monitoring (TDM)
10 Recruiting Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)
Condition: Advanced Breast Cancer
Intervention: Drug: PD-0332991 and T-DM1
Outcome Measures: Maximum Tolerated Dose (MTD);   Dose Limiting Toxicities (DLT)
11 Recruiting A Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
Intervention: Drug: trastuzumab emtansine
Outcome Measures: Objective response rate, defined as a complete response (CR) or partial response (PR) determined on two consecutive assessments >/= 4 weeks apart and based on investigator assessment according to RECIST v. 1.1;   Overall survival (OS);   Progression-free survival (PFS), defined as the time from first study drug administration to first documented disease progression, by investigator assessment using RECIST v1.1;   Duration of response (DOR), defined as the time from the initial documentation of objective response (CR or PR) to documented disease progression, using RECIST v1.1, or death from any cause;   Serum concentrations of trastuzumab emtansine and total trastuzumab;   Plasma concentration of DM1;   Incidence of adverse events (AEs)
12 Recruiting A Study of Trastuzumab Emtansine Versus Taxane in Patients With Advanced Gastric Cancer
Condition: Gastric Cancer
Interventions: Drug: taxane;   Drug: trastuzumab emtansine
Outcome Measures: Overall survival (OS);   Objective response rate (ORR);   Progression-free survival (PFS);   Duration of response (DOR);   Safety: incidence of adverse events;   Response distribution of treatment-related symptoms as measured by patient-reported outcome data;   Time to gastric cancer symptom progression as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ-STO22);   Quality of life as measured by the European Organization for Research and Treatment of Cancer questionnaire (EORTC QLQ C30);   Pharmacokinetics: serum concentration-time profile of trastuzumab emtansine;   Pharmacokinetics: serum concentration-time profile of total trastuzumab;   Pharmacokinetics: plasma concentration-time profile of DM1
13 Recruiting Trastuzumab & Pertuzumab Followed by T-DM1 in MBC
Condition: Metastatic Breast Cancer
Interventions: Drug: Trastuzumab;   Drug: Pertuzumab;   Drug: Paclitaxel;   Drug: Vinorelbine;   Drug: T-DM1
Outcome Measures: Overall survival (OS) - Analysis Population: ITT Population 1;   OS - Analysis Population: ITT Population 2;   Progression Free Survival (PFS) of first-line treatment ignoring first Central Nervous System (CNS) lesion;   PFS of second-line treatment;   PFS of second-line treatment ignoring first CNS lesion;   Time to failure of strategy (TFS) of first- plus second-line treatment;   Overall survival OS;   Objective response (OR) of first-line treatment (based on investigator assessment);   Disease control (DC) of first-line treatment (based on investigator assessment);   OR of second-line treatment (based on investigator assessment);   DC of second-line treatment (based on investigator assessment);   Adverse events (AEs) according to the NCI CTCAE v4.0 of first-line treatment;   AEs according to the NCI CTCAE v4.0 of second-line treatment;   AEs grade ≥2 until first progression (ignoring first CNS lesion);   Quality of Life (QoL);   PFS of third-line treatment
14 Recruiting A Study Comparing Kadcyla Plus Perjeta Treatment to Chemotherapy Combined With Herceptin Plus Perjeta in Patients With HER2-Positive Breast Cancer
Condition: Breast Cancer
Interventions: Drug: carboplatin;   Drug: docetaxel;   Drug: pertuzumab [Perjeta];   Drug: trastuzumab [Herceptin];   Drug: trastuzumab emtansine [Kadcyla]
Outcome Measures: Local evaluation of pathological complete response (pCR);   Event-free survival (EFS);   Invasive disease-free survival (IDFS);   Overall survival (OS);   Breast-conserving surgery rate;   Incidence of adverse events;   Incidence of hepatic events;   Incidence of cardiac events;   Health related quality of life as assessed by the European organization for reasearch and treatment of cancer (EORTC) quality of life questionnaire (QLQ) C30/BR23;   Observed drug serum concentrations;   Incidence of anti-therapeutic antibodies
15 Recruiting A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Condition: Breast Cancer
Interventions: Drug: anthracycline-based chemotherapy;   Drug: pertuzumab [Perjeta];   Drug: taxane;   Drug: trastuzumab [Herceptin];   Drug: trastuzumab emtansine [Kadcyla]
Outcome Measures: Invasive disease-free survival (IDFS), defined as time from randomization to occurrence of ipsilateral breast cancer recurrence, second primary invasive breast cancer, distant recurrence, or death of any cause;   IDFS plus second primary non-breast cancer, excluding non-melanoma skin cancers and carcinoma in situ of any site;   Disease-free survival (DFS), defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS);   Distant recurrence-free interval (DRFI), defined as time between randomization and first occurrence of distant breast cancer recurrence;   Overall survival;   Safety: Incidence of adverse events
16 Not yet recruiting Deciphering Antitumour Response and Resistance With INtratumour Heterogeneity
Condition: Non-small Cell Lung Cancer
Interventions: Drug: MPDL3280A;   Drug: Vemurafenib;   Drug: Alectinib;   Drug: Trastuzumab emtansine
Outcome Measures: Progression free survival (PFS), defined as the period between the date of registration to the date of subsequent progression or death (whichever occurs first).;   ORR, Investigator-assessed according to RECISTv1.1 and irRC (Arm 1 only);   Time to event outcomes - overall survival;   Time to event outcomes - progression;   Duration of response;   Toxicity, including dose reductions, interruptions, modifications and exposure;   Exploratory assessments include interrogation of recurrence and progression biopsies to decipher the molecular basis for resistance in combination with analyses of CTCs/cfDNA as well as CT imaging heterogeneity analyses.
17 Recruiting Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel
Condition: Breast Cancer
Interventions: Drug: Trastuzumab Emtansine;   Drug: Trastuzumab;   Drug: Lapatinib;   Drug: Abraxane;   Drug: Paclitaxel
Outcome Measures: pathological complete response rate (pCR);   Clinical Response Rate;   breast imaging response to treatment;   objective response rate;   toxicity, safety and efficacy of study treatment
18 Recruiting A Study of Kadcyla (Trastuzumab Emtansine) in Patients With HER2 Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
Condition: Breast Cancer
Intervention: Drug: Kadcyla (trastuzumab emtansine)
Outcome Measures: Safety: incidence of adverse events;   Progression-free survival according to response evaluation for solid tumors (RECIST) v.1.1;   Overall survival according to RECIST v.1.1;   Overall response rate according to RECIST v.1.1;   Clinical benefit rate according to RECIST v.1.1;   Duration of response according to RECIST v.1.1;   Time to response according to RECIST v.1.1
19 Not yet recruiting An Observational Study of Kadcyla Safety in Breast Cancer
Condition: Breast Cancer
Intervention:
Outcome Measures: Safety (composite outcome measure): Incidence of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs;   Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
20 Recruiting HER2 Imaging Study to Identify HER2 Positive Metastatic Breast Cancer Patient Unlikely to Benefit From T-DM1
Condition: HER-2 Positive Breast Cancer
Interventions: Drug: T-DM1;   Procedure: 89Zr-trastuzumab
Outcome Measures: negative predictive value of the 89Zr-trastuzumab PET/CT;   negative predictive value of the early FDG PET/CT;   negative predictive value of the combined 89Zr-trastuzumab PET/CT and early PET/CT

These studies may lead to new treatments and are adding insight into Kadcyla etiology and treatment.

A major focus of Kadcyla research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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