1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.

NCT02000596 | Terminated Phase 2 Results DMC

• 2 other identifiers: HP-00054959; 1303GCCGCC1303
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

HER2 overexpressed; Metastatic Breast Cancer; Elderly

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR) in Patients

  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.

  Participants were staged every two cycles for the duration of the study participation ( CR+PR+SD=ORR), up to 11 months

Secondary Outcomes (4)

• Progression-free Survival (PFS)

  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

• Overall Survival (OS)

  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.

• Number of Participants With Treatment Related Adverse Events as Assessed by CTCAE v4.0

  Participants were followed during the study and for 30 days after completion of the study treatment, up to 12 months

• Quality of Life Via Patient-reported Outcomes

  Duration of study, participants were followed every cycle up to 11 months.

Study Arms (3)

Cohort 1: T+P

EXPERIMENTAL

Trastuzumab plus Pertuzumab as first line treatment for HER2 overexpressed Metastatic Breast Cancer (without hormonal therapy or chemotherapy)

Drug: Trastuzumab plus Pertuzumab

Cohort 2 - Arm A

EXPERIMENTAL

Hormonal Therapy with Anastrozole and Fulvestrant in addition Trastuzumab plus Pertuzumab for women who progressed on T+P alone, and who are ER/PR +

Drug: Trastuzumab plus Pertuzumab; Drug: Hormonal Therapy with Anastrozole and Fulvestrant

Cohort 2 - Arm B

EXPERIMENTAL

Chemotherapy with Eribulin in addition to Trastuzumab plus Pertuzumab for women who progressed on T+P alone and who are ER/PR -

Drug: Trastuzumab plus Pertuzumab; Drug: Chemotherapy with Eribulin

Interventions

Trastuzumab plus Pertuzumab DRUG

Cohort 1: T+P; Cohort 2 - Arm A; Cohort 2 - Arm B

Hormonal Therapy with Anastrozole and Fulvestrant DRUG

Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days

Also known as: Anastrozole (Arimidex), Fulvestrant (Faslodex)

Cohort 2 - Arm A

Chemotherapy with Eribulin DRUG

Cohort 2 - Arm B

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Genentech, Inc.: collaborator

Study Sites (1)

University of Maryland Marlene & Stewart Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; pertuzumab; Anastrozole; Fulvestrant; Drug Therapy; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Therapeutics

Results Point of Contact

• Title: Kate Tkaczuk
• Organization: University of Maryland Greenebaum Comprehensive Cancer Center

ktkaczuk@umm.edu

410-328-7394

Study Officials

• Katherine Tkaczuk, MD

  University of Maryland Greenebaum Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: December 4, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: May 27, 2022
• Results First Posted: May 27, 2022

Record last verified: 2022-05

Locations

US (1)