A MULTICENTER, SINGLE ARM STUDY OF TRASTUZUMAB EMTANSINE (T-DM1) IN HER2 POSITIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER PATIENTS WHO HAVE RECEIVED PRIOR ANTI-HER2 AND CHEMOTHERAPY-BASED TREATMENT

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-130-12
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

1. HER2-POSITIVE DISEASE DETERMINED LOCALLY I.E., IHC 3 + AND/OR GENE-AMPLIFIED BY ISH AS PER INSTITUTIONAL PRACTICE, (HOWEVER, BOTH TESTS SHOULD BE PERFORMED WHEREVER POSSIBLE AND ONLY ONE POSITIVE RESULT IS REQUIRED FOR ELIGIBILITY)
2. HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED INVASIVE BC
3. PRIOR TREATMENT FOR BC IN THE ADJUVANT, UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC SETTING MUST INCLUDE BOTH CHEMOTHERAPY, ALONE OR IN COMBINATION WITH ANOTHER AGENT, AND AN ANTI-HER2 AGENT, ALONE OR IN COMBINATION WITH ANOTHER AGENT (COMPLEMENTARY HORMONAL THERAPY IS ALLOWED)
4. DOCUMENTED PROGRESSION OF INCURABLE, UNRESECTABLE, LOCALLY ADVANCED, OR MBC, DEFINED BY THE INVESTIGATOR: PROGRESSION MUST OCCUR DURING OR AFTER MOST RECENT TREATMENT FOR LOCALLY ADVANCED/MBC OR WITHIN 6 MONTHS OF COMPLETING ADJUVANT THERAPY
5. MEASURABLE AND/OR NON-MEASURABLE DISEASE
6. SIGNED WRITTEN INFORMED CONSENT APPROVED BY THE INSTITUTION´S INDEPENDENT ETHICAL COMMITTEE (EC)
7. AGE ≥ 18 YEARS
8. LEFT VENTRICULAR EJECTION FRACTION ≥ 50% BY EITHER ECHO OR MUGA
9. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS OF 0, 1 OR 2

Exclusion Criteria

1. HISTORY OF TREATMENT WITH TRASTUZUMAB EMTANSINE
2. PRIOR ENROLLMENT INTO A CLINICAL STUDY CONTAINING TRASTUZUMAB EMTANSINE REGARDLESS OF HAVING RECEIVED TRASTUZUMAB EMTANSINE OR NOT
3. PERIPHERAL NEUROPATHY OF GRADE ≥ 3 PER NCI CTCAE VERSION 4.0
4. HISTORY OF OTHER MALIGNANCY WITHIN THE PREVIOUS 5 YEARS, EXCEPT FOR APPROPRIATELY TREATED CARCINOMA IN SITU OF THE CERVIX, NON-MELANOMA SKIN CARCINOMA, STAGE 1 UTERINE CANCER, SYNCHRONOUS OR PREVIOUSLY DIAGNOSED HER2-POSITIVE BC, OR CANCERS WITH A SIMILAR CURATIVE OUTCOME AS THOSE MENTIONED ABOVE
5. HISTORY OF RECEIVING ANY ANTI-CANCER DRUG/BIOLOGIC OR INVESTIGATIONAL TREATMENT WITHIN 21 DAYS PRIOR TO FIRST STUDY TREATMENT EXCEPT HORMONE THERAPY, WHICH CAN BE GIVEN UP TO 7 DAYS PRIOR TO FIRST STUDY TREATMENT; RECOVERY OF TREATMENT-RELATED TOXICITY CONSISTENT WITH OTHER ELIGIBILITY CRITERIA
6. HISTORY OF EXPOSURE TO THE FOLLOWING CUMULATIVE DOSES OF ANTHRACYCLINES:
• DOXORUBICIN OR LIPOSOMAL DOXORUBICIN > 500 MG/M²
• EPIRUBICIN > 900 MG/M²
• MITOXANTRONE >120 MG/M²
• IF ANOTHER ANTHRACYCLINE, OR MORE THAN ONE ANTHRACYCLINE, HAS BEEN USED, THE CUMULATIVE DOSE MUST NOT EXCEED THE EQUIVALENT OF 500 MG/M² DOXORUBICIN
7. HISTORY OF RADIATION THERAPY WITHIN 14 DAYS OF FIRST STUDY TREATMENT. THE PATIENT MUST HAVE RECOVERED FROM ANY RESULTING ACUTE TOXICITY (TO GRADE ≥ 1) PRIOR TO FIRST STUDY TREATMENT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified