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Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1

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ClinicalTrials.gov Identifier: NCT01597414
Recruitment Status : Completed
First Posted : May 14, 2012
Last Update Posted : November 17, 2022
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Study Description
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Brief Summary:

Chemotherapy and HER2 targeted agents can improve survival significantly in metastatic breast cancer. Chemotherapy however is associated with significant side-effects and can impact on Quality of Life and functionality in older patients.

The investigators aim to establish HER2 targeted regimens with minimal toxicity in order to delay or even avoid the use of classical chemotherapy because of competing risks of death in this frail/elderly patient group.


Condition or disease Intervention/treatment Phase
Elderly Metastatic Breast Cancer Population Drug: Pertuzumab + trastuzumab Drug: Pertuzumab + trastuzumab + metronomic chemotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pertuzumab + trastuzumab (PH)
Pertuzumab + trastuzumab. After progression,patients will be given the option of receiving T-DM1
 Drug: Pertuzumab + trastuzumab

Trastuzumab: loading dose of 8 mg/kg of body weight on cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks.

Pertuzumab: loading dose of 840 mg on cycle 1, followed by 420 mg for subsequent cycles, every 3 weeks.

if T-DM1: 3.6 mg/kg IV, every 3 weeks.
Experimental: PH + metronomic chemotherapy (PHM)
Pertuzumab + trastuzumab + metronomic chemotherapy. After progression,patients will be given the option of receiving T-DM1
 Drug: Pertuzumab + trastuzumab + metronomic chemotherapy
Pertuzumab and trastuzumab will be administered as in arm A. Cyclophosphamide: daily dose of 50 mg/day. if T-DM1: as in arm A


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival rate [ Time Frame: 6 months after patients in ]

Secondary Outcome Measures :
  1. Overall survival
  2. Breast cancer specific survival
  3. Tumor response rate as measured by RECIST v1.1
  4. Evolution of HRQoL as assessed by EORTC QLQ-C30 and ELD 14 [ Time Frame: Up to 1 year after treatment start ]
  5. Evolution of geriatric assessment [ Time Frame: Up to 1 year after treatment start ]
  6. if T-DM1: progression free survival rate [ Time Frame: 6 months after start of T-DM1 treatment ]

Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597414


Locations
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Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Hoffmann-La Roche
Investigators
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Study Chair: Hans Wildiers, MD UZ Leuven, Leuven, Belgium
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT01597414    
Other Study ID Numbers: EORTC-75111-10114
2011-006342-32 ( EudraCT Number )
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: November 17, 2022
Last Verified: November 2022
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents