HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01370239 |
Recruitment Status :
Terminated
(futility)
First Posted : June 9, 2011
Last Update Posted : October 11, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Biological: Hu3S193 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Phase II Study of Treatment With Hu3S193 in Women With Advanced Breast Cancer That Progressed After Hormonal Therapy |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | October 2015 |
Actual Study Completion Date : | May 25, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Hu3S193
Single arm
|
Biological: Hu3S193
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. |
- Complete response, partial response or stable disease. [ Time Frame: more than 24 weeks ]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
- Response rate [ Time Frame: 24 weeks after patient discontinuation (at minimum) ]from inclusion until disease progression or death
- Non progression rate [ Time Frame: 24 weeks after patient discontinuation (at minimum) ]From patient inclusion until disease progression or death - evaluated radiologically by CT
- Overall survival [ Time Frame: 24 weeks after patient discontinuation (at minimum) or until death ]until death
- Progression free survival [ Time Frame: until disease progression or 24 weeks after patient discontinuation (at minimum) ]Evaluated radiologically by CT
- Assessment of any sign, symptom or undesirable medical condition that occurs after the first administration of the investigational agent [ Time Frame: Until disease progression or 30 days after patient discontinuation ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)

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): NCT01370239
Brazil | |
Universidade Federal Do Ceará | |
Fortaleza, Ceará, Brazil | |
PONTIFíCIA UNIVERSIDADE CATÓLICA DO RIO GRANDE DO SUL | |
Porto Alegre, RIO Grande DO SUL, Brazil | |
Hospital Do Câncer de Barretos | |
Barretos, SÃO Paulo, Brazil | |
Universidade Federal de Goias | |
Goias, Brazil | |
Instituto Nacional Do Câncer | |
Rio de Janeiro, Brazil | |
Instituto Do Câncer Do Estado de São Paulo | |
Sao Paulo, Brazil, 01246-000 | |
Hospital Sirio Libanes | |
Sao Paulo, Brazil |
Study Director: | PAULO MG HOFF, MD Professor | INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO | |
Study Director: | SERGIO V SERRANO, MD | HOSPITAL DO CÂNCER DE BARRETOS |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Paulo Marcelo Gehn Hoff, FACP MD PhD, Full Professor, Instituto do Cancer do Estado de São Paulo |
ClinicalTrials.gov Identifier: | NCT01370239 |
Other Study ID Numbers: |
52/2009 |
First Posted: | June 9, 2011 Key Record Dates |
Last Update Posted: | October 11, 2019 |
Last Verified: | October 2019 |
monoclonal antibody Lewis breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |