A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
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ClinicalTrials.gov Identifier: NCT00875979 |
Recruitment Status :
Completed
First Posted : April 6, 2009
Results First Posted : July 18, 2013
Last Update Posted : December 24, 2013
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Breast Cancer | Drug: Trastuzumab emtansine [Kadcyla] 3.0 mg/kg Drug: Trastuzumab emtansine [Kadcyla] 3.6 mg/kg Drug: Pertuzumab 420 mg | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 67 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase Ib/II, Open-label Study of the Safety, Tolerability, and Efficacy of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab |
Study Start Date : | May 2009 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Trastuzumab emtansine 3.0 mg/kg + pertuzumab 420 mg
Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
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Drug: Trastuzumab emtansine [Kadcyla] 3.0 mg/kg
Trastuzumab emtansine was provided as a single-use lyophilized formulation.
Other Names:
Drug: Pertuzumab 420 mg Pertuzumab was provided as a single-use formulation.
Other Name: Perjeta |
Experimental: Trastuzumab emtansine 3.6 mg/kg + pertuzumab 420 mg
Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
|
Drug: Trastuzumab emtansine [Kadcyla] 3.6 mg/kg
Trastuzumab emtansine was provided as a single-use lyophilized formulation.
Other Names:
Drug: Pertuzumab 420 mg Pertuzumab was provided as a single-use formulation.
Other Name: Perjeta |
- Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline through the end of the study (up to 2 years 3 months) ]A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions.
- Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline through the end of the study (up to 2 years 3 months) ]Duration of objective response was defined as the time from initial response to disease progression (PD) or death from any cause. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.
- Progression-free Survival Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Baseline through the end of the study (up to 2 years 3 months) ]Progression-free survival was defined as the time from randomization to first documented disease progression (PD) or death due to any cause within 30 days of the last treatment, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeated measurements by imaging techniques or clinically. All measurable lesions up to a maximum of 5 lesions per organ and 10 lesions in total, representative of all involved organs, should be identified as target lesions.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically documented human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer.
- Tumor tissue blocks or 15-20 unstained tissue slides for confirmatory central laboratory HER2 status testing and other exploratory assessments.
- Prior trastuzumab in any line of therapy.
- No prior trastuzumab emtansine (T-DM1) or pertuzumab therapy.
- Measurable disease.
- For women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of the study.
- Life expectancy ≥ 90 days.
Exclusion Criteria:
- Less than 21 days since the last anti-tumor therapy, including chemotherapy, biologic, experimental, immune, hormonal, or radiotherapy for the treatment of breast cancer, with the following exceptions: Hormone-replacement therapy or oral contraceptives; palliative radiation therapy involving ≤ 25% of marrow-bearing bone if administered ≥ 14 days prior to first study treatment.
- History of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued.
- Peripheral neuropathy of Grade ≥ 2.
- History of clinically significant cardiac dysfunction.
- Current severe, uncontrolled systemic disease, eg, clinically significant cardiovascular, pulmonary, or metabolic disease.
- Brain metastases that are untreated, progressive, or have required any type of therapy to control symptoms from brain metastases within 60 days of the first study treatment.
- History of other malignancy within the last 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875979
United States, Florida | |
Boca Raton, Florida, United States, 33428 | |
Deerfield Beach, Florida, United States, 33442 | |
United States, Illinois | |
Maywood, Illinois, United States, 60153 | |
United States, Indiana | |
Indianapolis, Indiana, United States, 46202 | |
United States, Kansas | |
Wichita, Kansas, United States, 67214 | |
United States, Maryland | |
Rockville, Maryland, United States, 20850-3348 | |
United States, North Carolina | |
Chapel Hill, North Carolina, United States, 27514 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Tennessee | |
Nashville, Tennessee, United States, 37203 | |
Belgium | |
Bruxelles, Belgium, 1000 | |
Canada, British Columbia | |
Vancouver, British Columbia, Canada, V5Z 1H5 | |
Canada, Quebec | |
Montreal, Quebec, Canada, H3A 1A1 | |
France | |
Paris, France, 75248 | |
Villejuif, France, 94805 | |
Germany | |
Köln, Germany, 50924 | |
Italy | |
Aviano, Italy, 33081 | |
Milano, Italy, 20133 | |
Spain | |
Barcelona, Spain, 08035 | |
Valencia, Spain, 46010 |
Study Director: | Elaine K. Wong, M.Sc., M.D. | Genentech, Inc. |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00875979 |
Other Study ID Numbers: |
BO22495 TDM4373g ( Other Identifier: Genentech ) |
First Posted: | April 6, 2009 Key Record Dates |
Results First Posted: | July 18, 2013 |
Last Update Posted: | December 24, 2013 |
Last Verified: | December 2013 |
MBC Breast Cancer HER2+ HER2+ breast cancer |
HER2 positive breast cancer herceptin Trastuzumab emtansine |
Pertuzumab Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Trastuzumab Ado-trastuzumab emtansine |
Maytansine Antineoplastic Agents, Immunological Antineoplastic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |