Know Cancer

or
forgot password

A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy


This is a national study, open label, single arm, phase II study which will be conducted in
seven centers in Brazil. The study will be coordinated by the INSTITUTO DO CÂNCER DO ESTADO
DE SÃO PAULO in collaboration with RECEPTA Biopharma. The study is funded by the CONSELHO
NACIONAL DE DESENVOLVIMENTO CIENTÍFICO E TECNOLÓGICO (CNPq). Before any procedure relating
to the study, patients must read and sign the informed consent (IC). The inclusion of
patients begin immediately after regulatory approval and is expected to end after reaching
the number of patients. The follow-up term will last at least 24 months for each patient
included, unless limited by death, loss to follow up or withdrawal of informed consent. A
total of 60 patients will be recruited in this study. The eligible patients must be 18 or
older, confirmed diagnosis of breast cancer with locally advanced or metastatic progression
after one or two lines of previous hormone treatment, confirmation of Lewis antigen
expression -as assessed by central laboratory, measurable or evaluable disease and adequate
organ function. Patients will receive weekly intravenous doses of the antibody Hu3S193 until
disease progression, unacceptable toxicity, withdrawal of consent or the investigator's
decision, whichever occurs first. The study's primary endpoint is the clinical benefit rate.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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);

- Previous chemotherapy for metastatic disease (adjuvant chemotherapy is acceptable, if
more than four weeks between its completion and inclusion in the study;

- Radiotherapy within 4 weeks before inclusion in the study or with no recovery from
the toxic effects of radiotherapy when done up to 6 weeks before inclusion in the
study, except for palliative radiotherapy for bone metastases involving <25 % bone
marrow;

- Treatment with biological agents, immunotherapy or surgery within 4 weeks before
inclusion in the study or with no recovery from the toxic effects of these treatments
when made until six weeks prior to study entry (prior treatment with bisphosphonates
is allowed, it can be continued after inclusion in 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response, partial response or stable disease.

Outcome Description:

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

Outcome Time Frame:

more than 24 weeks

Safety Issue:

No

Principal Investigator

PAULO MG HOFF, MD Professor

Investigator Role:

Study Director

Investigator Affiliation:

INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO

Authority:

Brazil: Ethics Committee

Study ID:

52/2009

NCT ID:

NCT01370239

Start Date:

July 2013

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • monoclonal antibody
  • Lewis
  • breast cancer
  • Breast Neoplasms

Name

Location