Clinical trial · Interventional
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pertuzumab | Drug | Pertuzumab | ALIAS |
| pertuzumab-placebo | Drug | — | UNRESOLVED |
| trastuzumab emtansine | Drug | Trastuzumab Emtansine | ALIAS |
| trastuzumab [Herceptin] | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Trastuzumab + Taxane (docetaxel or paclitaxel)
- interventionNames
- Drug: docetaxel
- Drug: paclitaxel
- Drug: trastuzumab [Herceptin]
- type
- EXPERIMENTAL
- label
- Trastuzumab emtansine + pertuzumab
- interventionNames
- Drug: pertuzumab
- Drug: trastuzumab emtansine
- type
- EXPERIMENTAL
- label
- Trastuzumab emtansine + pertuzumab placebo
- interventionNames
- Drug: pertuzumab-placebo
- Drug: trastuzumab emtansine
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult participants \>/=18 years of age * HER2-positive breast cancer * Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and be a candidate for chemotherapy. Participants with locally advanced disease must have recurrent or progressive disease, which must not be amenable to resection with curative intent. * Participants must have measurable and/or non-measurable disease which must be evaluable per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 * Adequate organ function as determined by laboratory results Exclusion Criteria: * History of prior (or any) chemotherapy for metastatic breast cancer or recurrent locally advanced disease * An interval of \<6 months from the last dose of vinca-alkaloid or taxane cytotoxic chemotherapy until the time of metastatic diagnosis * Hormone therapy \<7 days prior to randomization * Trastuzumab therapy and/or lapatinib (neo- or adjuvant setting) \<21 days prior to randomization * Prior trastuzumab emtansine or pertuzumab therapy
References
Publications (3)
- DERIVEDPerez EA, de Haas SL, Eiermann W, Barrios CH, Toi M, Im YH, Conte PF, Martin M, Pienkowski T, Pivot XB, Burris HA 3rd, Stanzel S, Patre M, Ellis PA. Relationship between tumor biomarkers and efficacy in MARIANNE, a phase III study of trastuzumab emtansine +/- pertuzumab versus trastuzumab plus taxane in HER2-positive advanced breast cancer. BMC Cancer. 2019 May 30;19(1):517. doi: 10.1186/s12885-019-5687-0. PMID 31146717
- DERIVEDBighin C, Pronzato P, Del Mastro L. Trastuzumab emtansine in the treatment of HER-2-positive metastatic breast cancer patients. Future Oncol. 2013 Jul;9(7):955-7. doi: 10.2217/fon.13.74. PMID 23837759
- DERIVEDScott AM, Wolchok JD, Old LJ. Antibody therapy of cancer. Nat Rev Cancer. 2012 Mar 22;12(4):278-87. doi: 10.1038/nrc3236. PMID 22437872