Phase 2
Completed N=153
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
Source: ClinicalTrials.gov NCT01196052 ↗Enrolled (actual)
153
Serious AEs
10.1%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment — 0 Percentage of participants
Summary
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Cardiac Event Within 12 Weeks After the Start of Trastuzumab Emtansine Treatment |
— | — |
| PRIMARY Adverse Events, LVEF Function, and Deaths |
98.6; 10.1; 13.5; 29.1; 21.6; 0.0 | — |
| SECONDARY Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Radiotherapy With Trastuzumab Emtansine Treatment |
94.9 | — |
| SECONDARY Percentage of Participants Who Experienced at Least 1 Adverse Event During Concurrent Hormonal Therapy With Trastuzumab Emtansine Treatment |
69.4 | — |
| SECONDARY Percentage of Participants Who Completed the Planned Duration of Trastuzumab Emtansine Treatment |
82.4 | — |
| SECONDARY Percentage of Participants Who Completed ≥ 95% of the Planned Radiotherapy Treatment With Concurrent Trastuzumab Emtansine Administration Without Significant (> 5 Days) Delay |
94.7 | — |
| SECONDARY Percentage of Participants With a Pathological Complete Response |
56.0 | — |
| SECONDARY Disease-free Survival at Month 12 |
— | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT01196052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.