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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01196052 |
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Date of registration:
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03/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer
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Scientific title:
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A Multicenter, Multinational Phase II Study to Assess the Clinical Safety and Feasibility of Trastuzumab Emtansine Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage HER2-positive Breast Cancer |
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Date of first enrolment:
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October 2010 |
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Target sample size:
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153 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01196052 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Korea, Republic of
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Poland
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Russian Federation
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Spain
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United States
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients = 18 years of age.
- Locally advanced, inflammatory, or early stage, unilateral, and histologically
confirmed invasive breast cancer documented at a local laboratory (patients with
inflammatory breast cancer must be able to have a core needle biopsy).
- Herceptin (HER)2-positive tumor, confirmed by central testing using
immunohistochemistry (IHC) and in situ hybridization (ISH) methods.
- Willingness to receive anthracycline-based chemotherapy or have received
doxorubicin/cyclophosphamide (AC) OR 5-fluorouracil (FU)/epirubicin/ cyclophosphamide
(FEC) in a similar dose and schedule as described in the protocol as part of
neoadjuvant or adjuvant treatment.
- For women of childbearing potential and men with partners of childbearing potential,
agreement to use a highly effective, non-hormonal form of contraception or 2 effective
forms of non-hormonal contraception by the patient and/or partner. Contraception use
must continue for the duration of study treatment and for at least 6 months after the
last dose of study treatment. Male patients should use condoms for the duration of the
study. Specific country requirements will be followed.
- Negative results of serum pregnancy test for premenopausal women of reproductive
capacity and for women < 12 months after menopause.
- Patients may enroll before or after AC/FEC chemotherapy has completed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, biochemistry, and cardiac assessments.
Exclusion Criteria:
- Stage IV breast cancer or bilateral breast cancer.
- Pregnant or breastfeeding women.
- History of other malignancy within the previous 5 years, except contralateral breast
cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ (LCIS),
appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma,
Stage I uterine cancer, or other cancers with outcome similar to those mentioned
above.
- Radiation therapy, immunotherapy, or biotherapy within 5 years before study
enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study
enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study
treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be
allowed to enroll in the study after the completion of their AC/FEC. No other prior
history of cardiotoxic chemotherapy is allowed.
- Active cardiac history.
- Current chronic daily treatment with oral corticosteroids or equivalent.
- Patients with severe dyspnea at rest or requiring supplementary oxygen therapy.
- Active, unresolved infections at screening.
- Human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus
(HCV) infection.
- Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer.
- Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet
radiation therapy is planned.
- Known hypersensitivity to any of the study drugs or derivatives, including murine
proteins.
- Grade = 2 peripheral neuropathy at Baseline.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Trastuzumab emtansine
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Primary Outcome(s)
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Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment
[Time Frame: Baseline to 12 weeks after the start of trastuzumab emtansine treatment]
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Adverse Events, LVEF Function, and Deaths
[Time Frame: From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)]
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Secondary Outcome(s)
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Percentage of Participants Who Completed = 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay
[Time Frame: From the start to the end of radiotherapy treatment (up to 51 weeks)]
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Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment
[Time Frame: From the start to the end of trastuzumab emtansine treatment (up to 51 weeks)]
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Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment
[Time Frame: From the start to the end of concurrent hormonal therapy (up to 51 weeks)]
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Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment
[Time Frame: From the start to the end of concurrent radiotherapy (up to 51 weeks)]
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Percentage of Participants With a Pathological Complete Response
[Time Frame: Day of surgery]
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Disease-free Survival at Month 12
[Time Frame: From the start of trastuzumab emtansine for adjuvant patients and from the date of surgery for neoadjuvant patients to 12 months later]
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Secondary ID(s)
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TDM4874g
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BO22857
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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