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Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group


Phase 2
60 Years
N/A
Not Enrolling
Female
Elderly Metastatic Breast Cancer Population

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Trial Information

Pertuzumab + Trastuzumab (PH) Versus PH Plus Metronomic Chemotherapy (PHM) in the Elderly HER2+ Metastatic Breast Cancer Population Who May Continue on T-DM1 Alone Following Disease Progression While on PH / PHM: an Open-label Multicentre Randomized Phase II Selection Trial of the EORTC Elderly Task Force and Breast Cancer Group


Inclusion Criteria:



- Female patients with histologically proven HER-2 positive

- Newly diagnosed or recurrent (after surgery) stage IV disease (TNM/AJCC v.7).

- Patients must have measurable (RECIST v. 1.1) or evaluable disease

- Performance status (PS) 0-3 (WHO)

- Age ≥ 70 years of age, or ≥ 60 years old with required number of dependencies

- Life expectancy of more than 12 weeks

- Previous adjuvant chemotherapy/anti HER-2 therapy after surgery is allowed, given
that the time interval from end of previous treatment to initiation of treatment for
metastatic disease is ≥ 6 months.

- Up to one line of anti-HER therapy (trastuzumab or lapatinib) is allowed in
combination with hormone therapy for hormone sensitive metastatic breast cancer.

- Adequate organ function

- Before patient randomization, written informed consent must be given according to
ICH/GCP, and national/local regulations.

Exclusion Criteria:

- No brain metastases that are untreated, symptomatic, or require steroids to control
symptoms; or any radiation, surgery, or other therapy to control symptoms from brain
metastases within 2 months prior to the first study treatment.

- No prior chemotherapy for metastatic disease is allowed

- No prior treatment with pertuzumab is allowed

- No history of exposure to the following cumulative doses of anthracyclines:

- Doxorubicin or liposomal doxorubicin > 360 mg/m2

- Epirubicin > 720 mg/m2

- Mitoxantrone > 120 mg/m2

- Idarubicin > 90 mg/m2

- If another anthracycline or more than 1 anthracycline has been used, then the
cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.

- No history of palliative radiotherapy within 14 days of randomization

- No history of other malignancy within the last 5 years, except for carcinoma in situ
of the cervix or basal cell or spinocellular carcinoma of the skin

- No current uncontrolled hypertension (persistent systolic > 180 mmHg and/or diastolic
> 100 mmHg)

- No LVEF below 50%

- No history of significant cardiac disease defined as:

- Symptomatic CHF (NYHA classes II-IV)

- High-risk uncontrolled arrhythmias

- History of myocardial infarction within 6 months prior to randomization

- Clinically significant valvular heart disease

- No angina pectoris requiring anti-angina treatment

- No peripheral neuropathy of Grade ≥ 3 per NCI CTCAE version 4.0.

- No current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or
bone fractures, known infection with HIV, active hepatitis B and/or hepatitis C
virus)

- No major surgical procedure or significant traumatic injury within 28 days prior to
randomization or anticipation of the need for major surgery during the course of
study treatment

- No history of receiving any investigational treatment within 28 days of randomization

- No history of intolerance (including Grade 3-4 infusion reaction) to trastuzumab

- No unwillingness or inability to comply with the requirements of the protocol as
assessed by the investigator

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the
trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival rate

Outcome Time Frame:

6 months after patients in

Safety Issue:

No

Principal Investigator

Hans Wildiers, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UZ Leuven, Leuven, Belgium

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

EORTC-75111-10114

NCT ID:

NCT01597414

Start Date:

Completion Date:

Related Keywords:

  • Elderly Metastatic Breast Cancer Population
  • Breast Neoplasms

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