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Breast CancerPhase 1NCT02619162

Nintedanib+Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Safety and Pharmacodynamics

A Phase 1 study testing Nintedanib and Letrozole in people with Breast Cancer, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 3 sites in Spain.

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

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. 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?
Nintedanib and Letrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
3 sitesSpain
Study dates
Jul 2015to Jun 2018
Phase
Phase 1
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

  • Form signed informed consent.
  • Women ≥ 18 years.
  • Confirmed diagnosis of invasive non-metastatic breast cancer positive for hormone receptors. The inclusion of patients with ductal or lobular histology allowed.
  • 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.
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  • 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
  • Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance> 50 ml / min
  • Serum bilirubin <1.25 ULN
  • AST / ALT ≤ 1.5 times the LS
  • Toxicities associated with chemotherapy recovery lesser extent 2 not tolerable.
  • Life expectancy> 6 months.

Who cannot join

  • 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.
  • Malignancy concomitant active, or diagnosis of another malignancy within the last five years, apart from non-melanoma or ductal / tubular breast carcinoma skin cancer (not received hormone treatment) or in situ cervical cancer, carcinoma colon in situ treated properly, as well as any diagnosis of tumor less than five years before the inclusion unsigned progression today.
  • Women of childbearing potential.
  • Pretreatment nintedanib. Use of other investigational drugs during the administration of adjuvant or neoadjuvant treatment is not an exclusion criterion as long as toxicity recovers.
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  • Medical Condition concomitant serious, like eg myocardial infarction within 6 uncontrolled prior to inclusion in the study months, congestive heart failure, unstable angina, cardiomyopathy active, unstable ventricular arrhythmia, hypertension (according to the criteria of the NYHA) , psychotic disorders uncontrolled severe active infections, active peptic ulcer disease, psychiatric disease, HIV infection, active hepatitis, COPD or any other medical condition that might be aggravated by treatment or limits compliance.
  • 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).

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada, Madrid, 28942

  • Hospital de La Princesa

    Madrid, 28006

  • Clínica Quirón

    Madrid, 28223

Other trials in Spain

About this study

Official title: Nintedanib Plus Letrozole in Postmenopausal Women With Breast Cancer: Clinical Trial Phase 0/1 Safety and Pharmacodynamics

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.

Read the detailed description

Phase 0 / I:

At level 1 it includes three patients. If any patient suffers dose limiting toxicity (DLT), it proceeds to the increase in dose to the next level. If 2/3 patients experience DLT, he will close the increased dose and extended / investigate the previous dose level with 3 additional patients.

If the level 2, but less than 1/3 the minimum of 6 patients experience TLD is reached, the phase I be suspended because not expected another rise above Level 2.

Dose levels:

  • Level 1: Nintedanib 150 mg twice daily + oral letrozole 2.5 mg / day orally, in a cycle of 28 days.
  • Level 2: Nintedanib 200 mg twice daily via oral + letrozole 2.5 mg / day orally, in a cycle of 28 days.
  • At least the first cycle will be administered during Phase I. A total of six four-week cycles were administered at the discretion of the investigator.
Conditions
Breast Cancer
Being tested
Nintedanib, Letrozole
Keywords
breast cancer non metastatic, adjuvant letrozole, Nintedanib BIFF1120
Medical subject headings
Breast Neoplasms

What participants receive

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

  • NintedanibDrug

    Also called BIFF 1120

    Tablets of 100 mg. or 150 mg.

  • LetrozoleDrug

    Tablet of 2.5 mg.

Study groups in NCT02619162
Study groupRoleWhat they receive
Letrozole+NintedanibExperimentalLetrozole+Nintedanib
Receives: Drug: Nintedanib; Drug: Letrozole

What is being measured

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

  1. Dose limiting toxicity

    Classified according to the version 4.03 of CTCAE criteria NCI1

    Measured: 1-6 months

Secondary outcomes (2)

  1. Evaluating FGFR1 modulation and inhibition levels of 17-B Estradiol

    Assess the pharmacodynamic modulation of FGFR1 and inhibition levels of 17-B: determine plasma levels of FGF 23 ang 17- B estradiol (pg/mL)

    Measured: 1-6 months

  2. Pharmacokinetic interactions

    Determine the pharmacokinetic interactions nintedanib combined with letrozole: determine plasma levels of Nintedanib and Letrozole at day 0, day 15 and day 29 (Cmax)

    Measured: 29 days

Timeline

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

  1. First posted2 Dec 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionNov 2017
  4. Study completionJun 2018

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02619162
Sponsor's protocol ID
CNIO-BR-007
Status last verified
Jul 2019
First submitted
15 Oct 2015
Last updated
23 Jul 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 31126332

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nintedanib and Letrozole in people with Breast Cancer, run by Centro Nacional de Investigaciones Oncologicas CARLOS III at 3 sites in Spain.

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 21 inclusion and 12 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 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Dose limiting toxicity (time frame: 1-6 months). 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 NCT02619162, 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 23 Jul 2019.

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