A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer

• Status: Withdrawn
• Trial end date: 2019-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting.

The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: iOMEDICO AG
• Collaborators: Amgen; Arbeitsgemeinschaft fur Internistische Onkologie
• Treatments: Docetaxel; Pertuzumab; Trastuzumab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Signed and dated written informed consent prior to beginning of protocol-specific procedures.

• Histologically or cytologically confirmed adenocarcinoma of the breast. Locally advanced and inoperable or metastatic disease.

• HER2-positive disease, defined as IHC status HER2+++ or CISH/FISH status positive.

• Female patients aged ≥ 18 years.

• In case of adjuvant treatment, disease-free interval of at least 12 months after completion of adjuvant treatment (excluding hormonal therapy).

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Left Ventricular Ejection Fraction (LVEF) ≥ 50%.

• For women with childbearing potential, defined as physiologically capable of becoming pregnant:

• Negative pregnancy test.

• Agreement to use an effective form of contraception during study treatment and for 7 months after the last dose of study treatment.

• Life expectancy of at least 12 weeks.

• Adequate organ and bone marrow function

• Fluent in spoken and written German and willing to answer the questionnaires

Exclusion Criteria:

• Previous systemic treatment in palliative intention (chemotherapy, hormonal therapy and / or biological therapy)

• Persistent peripheral sensory or motor neuropathy grade 2 or higher (NCI CTCAE v5.0)

• Evidence of central nervous system metastases. CT or MRI of the brain is only mandatory in case of clinical suspicion of brain metastases

• Current uncontrolled hypertension (systolic > 150 mmHg and / or diastolic > 100 mmHg) or clinically significant cardiovascular disease

• History of LVEF < 50% during or after prior (neo)adjuvant therapy with trastuzumab

• Current severe, uncontrolled systemic disease (e.g. cardiovascular, pulmonary, or metabolic disease, wound healing disorder, ulcers, or bone fractures, or severe fungal, bacterial or viral infection)

• Major surgery within 28 days prior to start of study medication, or anticipation of the need for major surgery during the course of study treatment

• Current known infection with HIV, HBV, or HCV (testing not required)

• Dyspnea at rest due to complications of advanced malignancy, or other diseases requiring continuous oxygen therapy.

• Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies.

• Participation in investigational studies within 30 days or five half-lives of the respective IMP, whichever is longer, prior randomization.

• Pregnant or lactating women.