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Last Updated: September 23, 2020

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CLINICAL TRIALS PROFILE FOR KADCYLA

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Biosimilar Clinical Trials for KADCYLA

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial ID Title Status Sponsor Phase Start Date Summary
NCT04266249 CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy Not yet recruiting National Cancer Institute (NCI) Phase 2 2020-02-11 This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
NCT04266249 CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy Not yet recruiting ECOG-ACRIN Cancer Research Group Phase 2 2020-02-11 This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
>Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for KADCYLA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01419197 A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy Completed Hoffmann-La Roche Phase 3 2011-09-01 This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or unresectable locally advanced/recurrent human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Eligible participants will be randomized to receive either trastuzumab emtansine 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Participants continue to receive study treatment until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.
NCT01702558 A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC) Active, not recruiting Hoffmann-La Roche Phase 2 2014-12-01 This multicenter study will assess the maximum tolerated dose of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase I design, followed by a randomized, open-label Phase II study to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, or withdrawal of consent.
NCT01966471 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 Pr Active, not recruiting Hoffmann-La Roche Phase 3 2014-01-01 This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combination with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenously (iv) every three weeks or Herceptin 6 mg/kg iv every three weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment is up to 1 year. Enrollment is complete for this study and a total of 1846 patients have been randomized.
NCT01983501 A Phase 1b Study of ONT-380 Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer Active, not recruiting Cascadian Therapeutics Inc. Phase 1 2014-02-01 The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended dose (RD) and to assess the safety and tolerability of ONT-380 combined with ado-trastuzumab emtansine (T-DM1) in patients with HER2+ breast cancer.
NCT02038010 BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx Active, not recruiting National Cancer Institute (NCI) Phase 1 2014-02-01 The purpose of this study is to see whether a combination of two different drugs - trastuzumab-MCC-DM1 (T-DM1) and BYL719 is safe, and if it might be effective in treating metastatic breast cancer. T-DM1 is a type of drug that contains an antibody (trastuzumab) linked to chemotherapy. The antibody in T-DM1 targets a marker on breast cancer cells called HER2, which allows the drug to go directly to the cancer cells. The use of T-DM1 in this study is considered standard treatment for the type of cancer in this study. Participants in this study have already been treated with trastuzumab and chemotherapy in the past, and their cancer has gotten worse in spite of those treatments. BYL719 is an oral drug (taken by mouth) that the researchers think may help T-DM1 to work better.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KADCYLA

Condition Name

Condition Name for KADCYLA
Intervention Trials
Breast Cancer 12
Metastatic Breast Cancer 6
HER2-positive Breast Cancer 5
Recurrent Breast Cancer 3
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Condition MeSH

Condition MeSH for KADCYLA
Intervention Trials
Breast Neoplasms 23
Neoplasms 2
Cholangiocarcinoma 1
Carcinoma 1
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Clinical Trial Locations for KADCYLA

Trials by Country

Trials by Country for KADCYLA
Location Trials
United States 150
Italy 21
Canada 18
Spain 14
Brazil 13
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Trials by US State

Trials by US State for KADCYLA
Location Trials
Tennessee 8
Massachusetts 8
Florida 6
Texas 6
New York 5
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Clinical Trial Progress for KADCYLA

Clinical Trial Phase

Clinical Trial Phase for KADCYLA
Clinical Trial Phase Trials
Phase 3 4
Phase 2/Phase 3 1
Phase 2 13
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Clinical Trial Status

Clinical Trial Status for KADCYLA
Clinical Trial Phase Trials
Not yet recruiting 12
Recruiting 10
Active, not recruiting 5
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Clinical Trial Sponsors for KADCYLA

Sponsor Name

Sponsor Name for KADCYLA
Sponsor Trials
Hoffmann-La Roche 8
National Cancer Institute (NCI) 5
Dana-Farber Cancer Institute 4
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Sponsor Type

Sponsor Type for KADCYLA
Sponsor Trials
Other 22
Industry 21
NIH 5
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