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Breast CancerPhase 2NCT01606072

Perioperative Use of Desmopressin (DDAVP) in Breast Cancer

A Phase 2 study testing Desmopressin in people with Breast Cancer, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product. Read more about this study

Who is it for?
Ages 21 to 60 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Desmopressin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteArgentina
Study dates
Nov 2011to Jul 2015
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 21 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • a. Female subjects from 21 to 60 years of age, who have voluntarily signed the informed consent form.
  • Histological/cytological diagnosis of breast carcinoma obtained at least 21 days before inclusion into the study.
  • Candidate for radical mastectomy and requiring resection of axillary lymph nodes or sentinel node.
  • In case of women of childbearing potential, an adequate birth control method (intrauterine device, barrier methods, or tubal ligation) should be used throughout the study. Post-menopausal women should have menopause confirmed by biochemical parameters.
  • Adequate organic function, defined by the following parameters:
  • Electrocardiogram (ECG) with no significant anomalies, performed within 14 days prior to surgery.
Show all 17Show fewer
  • The following laboratory results, obtained 7 days before surgery:
  • Hemoglobin ≥ 11 g/dL
  • Total white blood cell count ≥ 4,000/mm3
  • Total neutrophil count 1,500/mm3
  • Platelet count within normal limits
  • Total bilirubin ≤1.5 x UNL or 2.5 x UNL in case of hepatic metastasis
  • Transaminases ALT/GPT and AST/GOT ≤ 1.5 x UNL
  • Creatinine clearance >50 mg/dL
  • CT scan with oral and endovenous contrast* of chest, pelvis, and abdomen, and bone scan, conducted within 28 days prior to surgery. Images taken not longer than 90 days before surgery are also acceptable.
  • In case contrast is contraindicated, CT with no contrast or MRI will be performed.
  • Subject with performance status (ECOG) = 0.

Who cannot join

  • a. Synchronic bilateral breast cancer. b. Symptoms of metastasis or evidence of metastasis from images: chest spiral CT scan, abdomen/pelvis spiral CT scan, brain spiral CT/MRI (in case of brain metastasis signs), and bone scan.
  • The patient is pregnant or breastfeeding. d. The patient is presently using hormonal contraceptives or under hormonal treatment. She would be eligible if oral contraceptives were discontinued or if the hormonal treatment finished 30 days before surgery and the patient agreed to use another contraceptive method.
  • Patients with a history or presence of congestive heart failure, blood hypertension, angina pectoris or heart arrhythmia, thromboembolic disease, diabetes type I or II, or any underlying coronaropathy detected in pre-surgical evaluations.
  • Mentally-impaired patients. g. Patients with known hypersensitivity to DDAVP or vasopressin, o with severe von Willebrand's disease (VWD), defined by a VWF activity <10%IU/dL, or type 2B VWD, defined by an increased ristocetin-induced platelet aggregation (RIPA) at low concentrations of ristocetin or with hemophilia.
  • Patients with a history of seizures. i. Patients with renal impairment (creatinine clearance < 50 mL/min calculated by the Cockcroft-Gault formula), hyponatremia or with a history of hyponatremia.
  • Patients with syndrome of inadequate secretion of antidiuretic hormone. k. Patients with positive serology for the hepatitis B or C virus and/or HIV. l. Patients with known hepatic disease (diagnosed cirrhosis, hepatic enzymes (GOT/GPT) > 1.5 x UNL, Total bilirubin > 1.5 x UNL).
  • Patients with active infections. n. Patients with other malignant diseases, with the exception of, non-melanoma skin cancer, or cervix cancer in situ, or any other tumor that has received adequate treatment and shows a disease-free time ≥ 5 years.
  • Patients participating in another clinical study or cases in which less than 4 weeks have elapsed since participation in another clinical study.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Hospital Interzonal General De Agudos EvaPeron

    Buenos Aires, Buenos Aires

Other trials in Argentina

About this study

Official title: Perioperative Administration of Desmopressin to Subjects With Breast Cancer: A Phase IIa, Dose-Escalation Study

The propose for this study is to evaluate the safety and tolerability of desmopressin when administered perioperatively to patients with breast cancer undergoing surgery as first treatment, and select the optimum dose for the clinical development of the product.

Read the detailed description

Breast cancer is one of the most commonly diagnosed malignancies among women, and its mortality is related to the capacity of tumor cells to invade and produce metastases. It is postulated that tumor manipulation during surgery results in the release of tumor cells into circulation or the lymphatic system, and that these released cells survive due to aggregation among them or with platelets through the formation of a fibrin layer on the embolus. Tumor cells surviving transportation through circulation will join blood vessels and invade vascular walls, forming metastases. The interruption of this process might reduce survival of tumor cells and thus the formation of metastases from breast cancer cells in the lungs or other tissues.

Conditions
Breast Cancer
Being tested
Desmopressin
Keywords
DDAVP
Medical subject headings
Breast Neoplasms

What participants receive

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

  • DesmopressinDrug

    20 patients in 5 groups 4 each, advancing progressively to each dose level.

Study groups in NCT01606072
Study groupRoleWhat they receive
DesmopressinExperimentalNot described
Receives: Drug: Desmopressin

What is being measured

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

  1. Selection of the higher safe dose level for ensuing clinical trials

    One of the three dose levels assessed in this study will be selected for further clinical testing in adults: 0,50 mg, 1,0 mg, 1,25 mg, 1,5 mg or 2,0 mg.

    Measured: Up to 2 years

Secondary outcomes (16)

  1. Evidence of V2 Receptor Expression

    Measured: Baseline

  2. Evidence of CTC (CIRCULATING TUMOR CELLS)

    Measured: Baseline

  3. Evidence of Von Willebrand factor antigen (VWF:Ag)

    Measured: Baseline

  4. Evidence of CTC (circulating tumor cells)

    Measured: 30 minutes pre surgery and 24 hours post the surgery

  5. Evidence of CTC (circulating tumor cells)

    Measured: 2 Weeks

  6. Evidence of CTC (circulating tumor cells)

    Measured: 1 Month

  7. Evidence of CTC (circulating tumor cells)

    Measured: 3 Months

  8. Evidence of CTC (circulating tumor cells)

    Measured: 6 Months

  9. Evidence of CTC (circulating tumor cells)

    Measured: 12 Months

  10. Evidence of Von Willebrand factor antigen (VWF:Ag)

    Measured: 120 minutes post the surgery

  11. Evidence of VWF activity (ristocetin cofactor, VWF:RCo)

    Measured: baseline

  12. Evidence of VWF activity (ristocetin cofactor, VWF:RCo)

    Measured: 120 minutes post the surgery

  13. Evidence of FVIII coagulant activity (FVIII:C)

    Measured: baseline

  14. Evidence of FVIII coagulant activity (FVIII:C)

    Measured: 120 minutes post the surgery

  15. Evidence of euglobulin lysis time

    Measured: baseline

  16. Evidence of euglobulin lysis time

    Measured: 120 minutes post the surgery

Timeline

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

  1. First posted25 May 2012 (estimated)
  2. Study startNov 2011
  3. Primary completionFeb 2015
  4. Study completionJul 2015

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
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01606072
Sponsor's protocol ID
DDAVP
Status last verified
Aug 2015
First submitted
11 May 2012
Last updated
28 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Weinberg RS, Grecco MO, Ferro GS, Seigelshifer DJ, Perroni NV, Terrier FJ, Sanchez-Luceros A, Maronna E, Sanchez-Marull R, Frahm I, Guthmann MD, Di Leo D, Spitzer E, Ciccia GN, Garona J, Pifano M, Torbidoni AV, Gomez DE, Ripoll GV, Gomez RE, Demarco IA, Alonso DF. A phase II dose-escalation trial of perioperative desmopressin (1-desamino-8-d-arginine vasopressin) in breast cancer patients. Springerplus. 2015 Aug 19;4:428. doi: 10.1186/s40064-015-1217-y. eCollection 2015.

    PubMed 26306290

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Desmopressin in people with Breast Cancer, run by Laboratorio Elea Phoenix S.A. at 1 site in Argentina.

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 17 inclusion and 8 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: finished, as of the sponsor's last update on 28 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Selection of the higher safe dose level for ensuing clinical trials (time frame: Up to 2 years). 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 NCT01606072, 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 28 Aug 2015.

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