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Breast CancerPhase 2NCT01370239

HumanaH - Hu3s193 in the Treatment of Advanced Breast Cancer After Hormonal Therapy

A Phase 2 study testing Hu3S193 in people with Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 7 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Hu3S193
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
7 sitesBrazil
Study dates
Nov 2013to 25 May 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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;
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  • 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)

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Brazil7 sites

  • Hospital Do Câncer de Barretos

    Barretos, São Paulo

  • Universidade Federal Do Ceará

    Fortaleza, Ceará

  • Universidade Federal de Goias

    Goiás

  • PONTIFíCIA UNIVERSIDADE CATÓLICA DO RIO GRANDE DO SUL

    Porto Alegre, Rio Grande do Sul

  • Instituto Nacional Do Câncer

    Rio de Janeiro

  • Instituto Do Câncer Do Estado de São Paulo

    São Paulo, 01246-000

  • Hospital Sirio Libanes

    São Paulo

Other trials in Brazil

About this study

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

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.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Hu3S193
Keywords
monoclonal antibody, Lewis, breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT01370239
Study groupRoleWhat they receive
Hu3S193ExperimentalSingle arm
Receives: Biological: Hu3S193

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: more than 24 weeks

Secondary outcomes (5)

  1. Response rate

    from inclusion until disease progression or death

    Measured: 24 weeks after patient discontinuation (at minimum)

  2. Non progression rate

    From patient inclusion until disease progression or death - evaluated radiologically by CT

    Measured: 24 weeks after patient discontinuation (at minimum)

  3. Overall survival

    until death

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

  4. Progression free survival

    Evaluated radiologically by CT

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

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

    Measured: Until disease progression or 30 days after patient discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2011 (estimated)
  2. Study startNov 2013
  3. Primary completionOct 2015
  4. Study completion25 May 2018

Why it stopped: futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01370239
Sponsor's protocol ID
52/2009
Status last verified
Oct 2019
First submitted
25 May 2011
Last updated
11 Oct 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34644735

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hu3S193 in people with Breast Cancer, run by Instituto do Cancer do Estado de São Paulo at 7 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: futility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response, partial response or stable disease. (time frame: more than 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01370239, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.

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