TDM1 trial (KATHERINE) Phase III
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
This study is currently recruiting participants. Verified July 2013 by Hoffmann-La Roche Sponsor: Hoffmann-La Roche Collaborators: National Surgical Adjuvant Breast and Bowel Project (NSABP) German Breast Group Information provided by (Responsible Party): Hoffmann-La Roche ClinicalTrials.gov Identifier: NCT01772472 First received: January 17, 2013 Last updated: July 29, 2013 Last verified: July 2013 History of Changes
http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Purpose This 2-arm, randomized, open-label study will evaluate the efficacy and safety of trastuzumab emtansine versus trastuzumab as adjuvant therapy in patients with HER2-positive breast cancer who have residual tumor present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will be randomized to receive either trastuzumab emtansine 3.6 mg/kg or trastuzumab 6 mg/kg intravenously every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given in addition if indicated. Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Official Title: A Randomized, Multicenter, Open-Label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy for Patients With HER2-Positive Primary Breast Cancer Who Have Residual Tumor Present Pathologically in the Breast or Axillary Lymph Nodes Following Preoperative Therapy Resource links provided by NLM: Genetics Home Reference related topics: breast cancer MedlinePlus related topics: Breast Cancer Cancer Drug Information available for: Trastuzumab Trastuzumab emtansine U.S. FDA Resources Further study details as provided by Hoffmann-La Roche: Primary Outcome Measures:
Secondary Outcome Measures:
Estimated Enrollment: 1484 Study Start Date: April 2013 Estimated Study Completion Date: March 2023 Estimated Primary Completion Date: March 2023 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: Trastuzumab emtansine Drug: trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks, 14 cycles Active Comparator: Trastuzumab Drug: trastuzumab 6 mg/kg intravenously every 3 weeks, 14 cycles http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Eligibility Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria:
http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT01772472 Contacts Contact: Reference Study ID Number: BO27938 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com http://www.clinicaltrials.gov/ct2/ht...frame/plus.gif Show 276 Study Locations Sponsors and Collaborators Hoffmann-La Roche National Surgical Adjuvant Breast and Bowel Project (NSABP) German Breast Group Investigators Study Director: Clinical Trials Hoffmann-La Roche http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif More Information No publications provided Responsible Party: Hoffmann-La Roche ClinicalTrials.gov Identifier: NCT01772472 History of Changes Other Study ID Numbers: BO27938, 2012-002018-37 Study First Received: January 17, 2013 Last Updated: July 29, 2013 Health Authority: United States: Food and Drug Administration Additional relevant MeSH terms: Breast Neoplasms Neoplasm, Residual Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Trastuzumab Maytansine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action ClinicalTrials.gov processed this record on August 01, 2013 |
Re: TDM1 trial (KATHERINE) Phase III
I could be very interested in this one!! However...I do not see one close to Nebraska...:(
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Re: TDM1 trial (KATHERINE) Phase III
Mister Sister,
You are not eligible because you did adjuvant chemo - after your mastectomy. This is for neoadjuvant, before surgeries. A nice vaccine trial might be good. |
Re: TDM1 trial (KATHERINE) Phase III
SISTER!! I read TOO far into this...it was late...looking for ALL I can find to KICK this...
Actually, when I had my first consult with my MO, he asked his "fellow" to see if there were any clinical studies available...!! Tomorrow, I have an echo, along with the beginnning of my first Herceptin...or to complete my year of herceptin, praying my EF holds up, and my body doesn't reject Herceptin along the road... I "check" on your studies... ":) |
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