NCT01370239

Brief Summary

The humanized monoclonal antibody against Lewis Y antigen (Hu3S193) has been demonstrated to be safe in previous studies and has also been indicated as potential intervention in breast cancer. The study of this new agent in advanced breast cancer may contribute to the development of new strategies for patients that progressed after hormonal treatment.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2013

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2011

Completed
2.4 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2018

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

1.9 years

First QC Date

May 25, 2011

Last Update Submit

October 9, 2019

Conditions

Breast Cancer

Keywords

monoclonal antibodyLewisbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Complete response, partial response or stable disease.

    The primary efficacy analysis will be done through the clinical benefit rate, as defined by the proportion of patients achieving best response, complete response, partial response or stable disease for more than 24 weeks

    more than 24 weeks

Secondary Outcomes (5)

  • Response rate

    24 weeks after patient discontinuation (at minimum)

  • Non progression rate

    24 weeks after patient discontinuation (at minimum)

  • Overall survival

    24 weeks after patient discontinuation (at minimum) or until death

  • Progression free survival

    until disease progression or 24 weeks after patient discontinuation (at minimum)

  • Assessment of any sign, symptom or undesirable medical condition that occurs after the first administration of the investigational agent

    Until disease progression or 30 days after patient discontinuation

Study Arms (1)

Hu3S193

EXPERIMENTAL

Single arm

Biological: Hu3S193

Interventions

Hu3S193BIOLOGICAL

Patients will receive weekly intravenous doses of 20 mg/m2 of the antibody Hu3S193. The infusion will take 60 ± 10 minutes. The antibody should be diluted in 500 mL of normal saline.

Hu3S193

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of breast cancer with locally advanced or metastatic (stages IIIB, IIIC or IV according to TNM classification), confirmed histologically with no intention to curative treatment by radiotherapy or surgery;
  • Clinical or radiological progression after one or two lines of previous hormone treatment, including adjuvant treatment;
  • Positive for ER and / or PR expression documented by IHC;
  • Confirmed expression of Lewis Y antigen by IHC;
  • Presenting the performance status of 0 or 1 according to Eastern Cooperative Oncology Group (ECOG);
  • Have a measurable or evaluable disease by Response of Evaluation Criteria in Solid Tumors (RECIST);
  • Adequate organ function, assessed by laboratory tests obtained at least 2 weeks before the first day of treatment and within the following parameters:
  • absolute neutrophil count ≥ 1.5 x 109 / L; platelet count ≥ 100 x 109 / L; serum bilirubin ≤ 2.0 mg / dL; AST/ALT ≤ 2.5 x upper limit of normal; serum creatinine ≤ 2.0 mg / dL;
  • Expected survival \> 12 weeks;
  • In patients with childbearing potential: Negative pregnancy confirmed by test done 21 days before the date of study treatment initiation;
  • Willingness and ability to comply with the protocol for the duration of the study.

You may not qualify if:

  • Patients subjected previously to more than two lines of hormonal therapy, including adjuvant treatment;
  • Presenting the amplification or overexpression of HER-2;
  • Systemic corticosteroids or immunosuppressive agents used concomitantly with the study or have used systemic corticosteroids or immunosuppressants in the last 14 days before the first dose of the investigational drug;
  • Visceral metastatic disease with life-threatening (as defined by extensive liver involvement), or symptomatic pulmonary lymphangitic carcinomatosis or any degree of cerebral or leptomeningeal involvement;
  • Previous or current history of clinically significant cardiac disease (class III or IV according to New York Heart Association);
  • Clinically significant arrhythmia;
  • History of myocardial infarction within the last 6 months;
  • Previous or current history of other severe diseases (eg, severe ascites requiring repeated drainage, active infections requiring antibiotics, bleeding, inflammatory bowel disease or chronic diseases that may interfere with obtaining accurate results of the study);
  • Any investigational agent treatment within 12 months prior to study entry, unless the investigator considers that the participation in the study may benefit the patient;
  • Previous or current history of another type of tumor, excluding skin cancer, melanoma, in situ cervix carcinoma or in situ ductal carcinoma or lobular breast if properly treated;
  • Uncontrolled hypercalcemia (defined as total calcium\> 11.5 mg / dL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Universidade Federal Do Ceará

Fortaleza, Ceará, Brazil

Location

PONTIFíCIA UNIVERSIDADE CATÓLICA DO RIO GRANDE DO SUL

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Do Câncer de Barretos

Barretos, São Paulo, Brazil

Location

Universidade Federal de Goias

Goiás, Brazil

Location

Instituto Nacional Do Câncer

Rio de Janeiro, Brazil

Location

Instituto Do Câncer Do Estado de São Paulo

São Paulo, 01246-000, Brazil

Location

Hospital Sirio Libanes

São Paulo, Brazil

Location

Related Publications (1)

  • Testa L, Mano M, Arai RJ, Bonadio RC, Serrano SV, Zorzetto MMC, Crocamo S, Smaletz O, Freitas-Junior R, Hoff PM. Phase II trial of humanized anti-Lewis Y monoclonal antibody for advanced hormone receptor-positive breast cancer that progressed following endocrine therapy. Clinics (Sao Paulo). 2021 Oct 11;76:e3146. doi: 10.6061/clinics/2021/e3146. eCollection 2021.

    PMID: 34644735DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hu3S193 monoclonal antibody

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • PAULO MG HOFF, MD Professor

    INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO

    STUDY DIRECTOR

  • SERGIO V SERRANO, MD

    HOSPITAL DO CÂNCER DE BARRETOS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FACP MD PhD, Full Professor

Study Record Dates

First Submitted

May 25, 2011

First Posted

June 9, 2011

Study Start

November 1, 2013

Primary Completion

October 1, 2015

Study Completion

May 25, 2018

Last Updated

October 11, 2019

Record last verified: 2019-10

Locations

BR(7)