- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000596
1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.
May 4, 2022 updated by: University of Maryland, Baltimore
1303GCC: Phase II Study of Trastuzumab and Pertuzumab Alone and in Combination With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over With HER2/Neu Overexpressed Locally Advanced and/or Metastatic Breast Carcinoma
This is a phase II study that combines Trastuzumab with Pertuzumab to see how it works in women age greater than 60 who have been diagnosed with HER2/neu overexpressed locally advanced and/or metastatic breast carcinoma.
Study Overview
Status
Terminated
Conditions
Detailed Description
Currently available standard therapies for HER2 overexpressed metastatic breast cancers (MBC) include treatments with chemotherapy or hormonal therapy, alone or in combination with medications that target HER2 gene, such as Trastuzumab or Pertuzumab.
This study will examine the effect of treating HER2 overexpressed MBC with the combination of Trastuzumab plus Pertuzumab, without hormonal or chemotherapy, as a first line treatment.
If patients progress on this treatment, they will receive hormonal or chemotherapy in addition to the Trastuzumab plus Pertuzumab treatment.
The objective is to see how the overall response rate for this treatment compares to other first line treatments in the same patient population.
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Marlene & Stewart Greenebaum Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women ≥60 Years of Age.
- Histologically confirmed, locally advanced (T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that progressed after treatment with standard treatment regimens in the adjuvant or neoadjuvant setting.
- Prior treatment with trastuzumab and/or lapatinib in the neo-adjuvant or adjuvant setting is allowed but not required. Lapatininb has to be discontinued > 21 days before the initiation of the T+P study treatments.
- Up to 3 prior chemo regimens for treatment of metastatic disease are allowed as long as the study subject is acceptable for study treatment with chemo required on this study in cohort 2 at progression on T+P.
- Patients may have had prior hormonal therapy with any hormonal agents as per section 3.1.5 of this protocol.
- Zometa or denosumab can be continued as per standard of care as long as started before the study treatment is started.
- HER2 positive breast cancer, as defined in Section 3.3 of this protocol
- Must have measurable or evaluable disease according to RECIST 1.1 criteria.
- Lab values obtained ≤7 days prior to registration as indicated in 3.1.9 of this protocol.
- ECOG Performance Status (PS) of 0, 1 or 2.
- LVEF at least 50% as determined by MUGA or ECHO.
- Life expectancy >3 months.
- Written informed consent.
- Willingness to return to study site for treatment and follow-up.
- Normal QTc interval defined on EKG as QTc ≤ 440 msec.
- Postmenopausal women defined in section 3.1.16 of this protocol.
Exclusion Criteria:
- Stage III or IV cancer, other than breast cancer, in ≤5 years prior to registration.
- Actively being treated for other malignancy.
- New York Heart Association Class III or IV cardiovascular disease.
- History of coronary heart failure (CHF)
- Current use of drugs known to prolong the QTc interval including Class Ia and III antiarrhythmics or history of congenital long QTc syndrome.
- Evidence of active brain metastasis including leptomeningeal involvement.
- Major surgery, chemotherapy, hormonal or immunologic therapy ≤3 weeks prior to registration.
- Radiotherapy ≤3 weeks prior to registration, except if to a non-target lesion only.
- Prior treatment with Pertuzumab, Eribulin, Fulvestrant or Anastrozole.
- Uncontrolled illness.
- Co-morbid systemic illnesses or other severe concurrent disease. See section 3.2.11.
- Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered.
- Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
- International normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 × ULN (unless on anticoagulation medication)
- Receipt of intravenous (IV) antibiotics for infection within 7 days prior to enrollment into the study.
- Current chronic daily treatment with corticosteroids. See section 3.2.16 of this protocol.
- Known hypersensitivity to any of the study treatments or to excipients of recombinant human or humanized antibodies.
- History of receiving any investigational treatment within 28 days prior to enrollment into the study.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1: T+P
Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)
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Experimental: Cohort 2 - Arm A
Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +
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Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m.
D1, D15, D28 then every 28-30 days
Other Names:
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Experimental: Cohort 2 - Arm B
Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Response Rate (ORR) in Patients
Time Frame: Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months
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Defined as the total of complete response (CR) defined as a disappearance of all target lesions, partial response (PR) defined as >= 30% decrease in the sum of the longest diameter of target lesions, and stable disease (SD) >= 27 weeks among the total number of participants as defined by the Response Evaluation in Solid Tumors (RECIST) 1.1 response criteria.
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Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free Survival (PFS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
|
Progression Free Survival in treatment cohorts 1 and 2 as well as arms A and B from the time on study until progression of disease or death
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
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Overall Survival (OS)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion, an average of 2 years.
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Overall survival (OS) in treatment cohorts 1 and 2 as well as arms A and B from the time on study until death
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed through study completion, an average of 2 years.
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Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0
Time Frame: Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 months
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the safety and tolerability of Trastuzumab and Pertuzumab alone and in combination with hormonal therapy or single agent chemotherapy.
in HER2+ MBC patients
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Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 months
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Quality of Life Via Patient-reported Outcomes
Time Frame: Duration of study, participants were followed every cycle up to 11 months.
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quality of life and treatment side effects via patient-reported and investigator reported outcomes
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Duration of study, participants were followed every cycle up to 11 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
January 1, 2016
Study Registration Dates
First Submitted
November 21, 2013
First Submitted That Met QC Criteria
November 26, 2013
First Posted (Estimate)
December 4, 2013
Study Record Updates
Last Update Posted (Actual)
May 27, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Antineoplastic Agents, Immunological
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Trastuzumab
- Fulvestrant
- Anastrozole
- Pertuzumab
Other Study ID Numbers
- HP-00054959; 1303GCC
- GCC1303 (Other Identifier: University of Maryland Greenebaum Cancer Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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