NCT02619162

Brief Summary

Open, multicenter phase I with gradual increase in dosage to evaluate the safety and tolerability of orally administered nintedanib plus letrozole orally (2.5 mg / day) for patients with breast cancer. Nintedanib is administered twice a day orally for 28 consecutive days (Days 1-28) in 4-week cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

2.3 years

First QC Date

October 15, 2015

Last Update Submit

July 22, 2019

Conditions

Breast Cancer

Keywords

breast cancer non metastaticadjuvant letrozoleNintedanib BIFF1120

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicity

    Classified according to the version 4.03 of CTCAE criteria NCI1

    1-6 months

Secondary Outcomes (2)

  • Evaluating FGFR1 modulation and inhibition levels of 17-B Estradiol

    1-6 months

  • Pharmacokinetic interactions

    29 days

Study Arms (1)

Letrozole+Nintedanib

EXPERIMENTAL

Letrozole+Nintedanib

Drug: NintedanibDrug: Letrozole

Interventions

NintedanibDRUG

Tablets of 100 mg. or 150 mg.

Also known as: BIFF 1120
Letrozole+Nintedanib
LetrozoleDRUG

Tablet of 2.5 mg.

Letrozole+Nintedanib

Eligibility Criteria

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

You may qualify if:

  • Form signed informed consent.
  • Women ≥ 18 years.
  • Size greater than 1 cm tumor and any N or N ≥ 1 and any T, including inflammatory breast cancer.
  • Absence of metastatic involvement.
  • Postmenopausal state. Postmenopausal status is defined as more than 24 months after the last menstrual period, or previous known ovariectomy, or chemical, determined by FSH, LH and estradiol 17-B according to the local laboratory values over 12 months without menstruation.
  • ECOG performance status of 0 or 1
  • At least one month after the end of radiotherapy and / or chemotherapy.
  • At least 6 weeks since major surgery.
  • Patients currently treated with letrozole less than 6 months.
  • Primary surgery for breast cancer already done. The elderly women with advanced local or regional tumors in which hormone treatment is administered as monotherapy, regardless of the intent of the surgery are not candidates.
  • LVEF\> 50%
  • Renal function, liver and adequate hematologic, defined by the following analytical results within 14 days prior to randomization or registration:
  • Absolute granulocyte count\> 1.5 x 109 / L
  • Absolute platelet count\> 100 x 109 / L
  • Hemoglobin\> 10 g / dl
  • +5 more criteria

You may not qualify if:

  • HER2 overexpression defined as positive by immunohistochemistry HER-2-positive 2+ 3+ or FISH / CISH.
  • Absence of tumor tissue file.
  • T1 N0 stage patients are excluded.
  • Women of childbearing potential.
  • Inability to make oral, or history of malabsorption syndrome medication.
  • Failure to comply with the study and follow-up procedures.
  • Anticoagulant therapy (except low-dose heparin or heparin washing as needed to maintain a permanent intravenous device) or antiplatelet therapy (except low-dose therapy with aspirin, less than 325 mg daily).
  • History of thromboembolic or hemorrhagic episodes that are clinically relevant in the past 6 months or hereditary predisposition to bleeding or thrombosis.
  • Contraindication to hormonal blockade or absence of hormone-blocking prescription from your doctor for any reason. Metastatic breast cancer or non-surgical (including inflammatory).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Hospital de La Princesa

Madrid, 28006, Spain

Location

Clínica Quirón

Madrid, 28223, Spain

Location

Related Publications (1)

  • Quintela-Fandino M, Apala JV, Malon D, Mouron S, Hornedo J, Gonzalez-Cortijo L, Colomer R, Guerra J. Nintedanib plus letrozole in early breast cancer: a phase 0/I pharmacodynamic, pharmacokinetic, and safety clinical trial of combined FGFR1 and aromatase inhibition. Breast Cancer Res. 2019 May 24;21(1):69. doi: 10.1186/s13058-019-1152-x.

    PMID: 31126332DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

nintedanibLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marta Cardona

    Fundacion CRIS de Investigación para Vencer el Cáncer

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2015

First Posted

December 2, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2017

Study Completion

June 1, 2018

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

ES(3)