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Recurrent Breast CancerPhase 2IND197NCT01147484

A Study of Foretinib in Patients With Recurrent/Metastatic Breast Cancer

A Phase 2 study testing Foretinib in people with Recurrent Breast Cancer, run by NCIC Clinical Trials Group at 9 sites in Canada.

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 purpose of this study is to find out what effects this new drug foretinib has on this type of breast cancer, called "triple negative" breast cancer because the cancer tissue is estrogen, progesterone and HER2 receptor negative. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Recurrent Breast Cancer
What is being tested?
Foretinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
9 sitesCanada
Study dates
2 Sep 2010to 13 Feb 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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed diagnosis of invasive breast cancer, that is estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor 2 (HER2) negative.
  • Formalin fixed paraffin embedded tissue available for central pathology review and translational studies. Patients entered on the second stage of accrual must have an accessible tumour lesion for biopsy.
  • Advanced or recurrent/ metastatic disease incurable with standard therapies.
  • Clinically and/or radiologically documented measurable disease. At least one site of disease must be unidimensionally measurable.
  • ECOG performance of 0, 1 or 2.
  • Age ≥ 18 years of age.
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  • Previous Therapy: Any treatment-related major organ toxicities must be recovered to ≤ grade 1.
  • Patients may have received adjuvant chemotherapy and/or one prior line of chemotherapy in the recurrent/metastatic setting. A minimum of 21 days since the last dose of chemotherapy must have elapsed prior to registration.
  • No prior therapy with a c-Met inhibitor or angiogenesis inhibitor. Other targeted agents are permissible provided a minimum of 21 days has elapsed since last day of targeted therapy and registration.
  • Prior radiation therapy permitted provided the patient has recovered from acute toxic effects of the radiation therapy prior to registration, and at least 21 days have elapsed from the day of the last fraction of radiation to the date of registration. Exceptions may be made for non-myelosuppressive radiation to peripheral areas.
  • Previous surgery permitted provided wound healing has occurred and at least 14 days have elapsed if surgery was major.
  • Granulocytes (AGC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L
  • Serum creatinine ≤ 1.2 x UNL; Total bilirubin ≤ 1.2 x UNL; ALT and AST ≤ 2 x UNL
  • Women must be post menopausal, surgically sterile or use a reliable form of contraception while on study and for 90 days after discontinuing therapy. Women of childbearing potential must have a pregnancy test taken and proven negative within 7 days prior to registration and must not be lactating.
  • Patients who require oral anticoagulants (coumadin, warfarin) are eligible
  • Patient consent must be obtained according to local Institutional and/or University Human Experimentation Committee requirements.
  • Protocol treatment must begin within 7 working days of patient registration.

Who cannot join

  • History of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
  • Resting BP consistently higher than systolic > 150 mmHg and/or diastolic > 100 mmHg (in the presence or absence of a stable dose of anti-hypertensive medication) or poorly controlled hypertension, history of labile hypertension or poor compliance with anti-hypertensive medication.
  • Appreciable cavitating or actively bleeding lesions.
  • Untreated brain or meningeal metastases. (Patients with neurologically stable and treated brain metastases who have discontinued corticosteroids at least two weeks prior to study registration and have no evidence of cavitation or hemorrhage are eligible).
  • Untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction. Patients with a significant cardiac history (even if controlled) or prior anthracycline exposure are required to have an LVEF > 50%.
  • GI tract disease resulting in an inability to absorb oral medication.
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  • Active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
  • Known hypersensitivity to the study drugs or their components.
  • Potent CYP3A4 inhibitors/inducers (e.g. ketoconazole, carbamazepine) must be discontinued at least 7 days prior to Day 1, Cycle 1.
  • Treatment, concurrent or within 3 weeks prior to registration, with other investigational drugs or anti-cancer therapy.
  • Proliferative diabetic retinopathy, retinal arteritis or hemorrhage.
  • History of pulmonary embolus or a deep vein thrombosis diagnosed and/or treated within 6 months prior to registration.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Canada9 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Hopital Charles LeMoyne

    Greenfield Park, Quebec, J4V 2H1

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Ottawa Health Research Institute - General Division

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

About this study

Official title: A Phase II Study of Foretinib in Patients With Estrogen Receptor (ER), Progesterone Receptor (PR), and Human Epidermal Growth Factor Receptor 2 (HER2) Negative, Recurrent/Metastatic Breast Cancer

The purpose of this study is to find out what effects this new drug foretinib has on this type of breast cancer, called "triple negative" breast cancer because the cancer tissue is estrogen, progesterone and HER2 receptor negative.

Read the detailed description

This research is being done because there is no treatment that will cure this type of cancer. Although some types of chemotherapy can cause this cancer to shrink for a time, better options are needed.

Being tested
Foretinib
Keywords
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.

  • ForetinibDrug

    foretinib, at a continuous oral daily dose of 60 mg

Study groups in NCT01147484
Study groupRoleWhat they receive
ForetinibExperimentalNot described
Receives: Drug: Foretinib

What is being measured

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

  1. Objective response and early progression rate

    All patients will be assessed for response at the end of every second cycle (every 8 weeks). Response and progression will be evaluated using RECIST 1.1.

    Measured: Every 8 weeks

Secondary outcomes (3)

  1. Adverse Events as a Measure of Safety and Tolerability

    All patients will be assessed for toxicity at the end of every cycle (every 4 weeks). Adverse events will be graded using CTCAE V4.0.

    Measured: every 4 weeks

  2. Relationship between response and biomarkers

    Archival tissue will be collected on all patients. Pre-treatment fresh tissue biopsies CTC's will be collected on all patients entered in the second stage of accrual. Translational research studies will be done as described in protocol section 17.0.

    Measured: 2 years (end of study)

  3. Biomarkers in Tumour cells

    Archival tissue will be collected on all patients. Pre-treatment fresh tissue biopsies CTC's will be collected on all patients entered in the second stage of accrual. Translational research studies will be done as described in protocol section 17.0.

    Measured: 2 years (end of study)

Timeline

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

  1. First posted22 Jun 2010 (estimated)
  2. Study start2 Sep 2010
  3. Primary completion14 Dec 2014
  4. Study completion13 Feb 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01147484
Sponsor's protocol ID
I197
Acronym
IND197
Status last verified
Apr 2020
First submitted
27 May 2010
Last updated
4 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Rayson D, Lupichuk S, Potvin K, Dent S, Shenkier T, Dhesy-Thind S, Ellard SL, Prady C, Salim M, Farmer P, Allo G, Tsao MS, Allan A, Ludkovski O, Bonomi M, Tu D, Hagerman L, Goodwin R, Eisenhauer E, Bradbury P. Canadian Cancer Trials Group IND197: a phase II study of foretinib in patients with estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2-negative recurrent or metastatic breast cancer. Breast Cancer Res Treat. 2016 May;157(1):109-16. doi: 10.1007/s10549-016-3812-1. Epub 2016 Apr 26.

    PubMed 27116183

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Foretinib in people with Recurrent Breast Cancer, run by NCIC Clinical Trials Group at 9 sites in Canada.

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 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 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Canada. 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?

Objective response and early progression rate (time frame: Every 8 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 NCT01147484, 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 4 Aug 2023.

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