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Breast CancerPhase 3VICTORIANENCT02730091

A Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

A Phase 3 study testing Letrozole, Anastrozole and Vinorelbine in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

Terminated

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

Official record
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Trial summary

This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole. The study will compare the efficacy and tolerability of oral metronomic vinorelbine administered in combination with letrozole or anastrozole, as treatment for hormone receptor-positive… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Letrozole, Anastrozole and Vinorelbine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteFrance
Study dates
24 Feb 2016to 23 Mar 2020
Phase
Phase 3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient has signed informed consent before any trial related activities and according to local guidelines
  • Women with advanced (inoperable loco regionally recurrent or metastatic) breast cancer
  • No prior systemic anti-cancer therapy for advanced disease.
  • Patient is postmenopausal. Postmenopausal status is defined either by:
  • Prior bilateral oophorectomy
  • Age > 60
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  • Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, or ovarian suppression) and/or FSH and estradiol in the postmenopausal range per local normal range
  • Patient has a histological and/or cytological confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory ( determined by >10% positive stained cells for estrogen receptor by IHC on the primary tumor or on metastatic site whichever the value of progesterone receptor).
  • Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
  • Patient must have either:
  • Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria or,
  • At least one lytic bone lesion or . Non measurable disease
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status <2
  • Patient has adequate bone marrow and organ function as defined by the following laboratory values:
  • Absolute neutrophil count ≥ 1.5 × 109/L
  • Platelets ≥ 100 × 109/L
  • Hemoglobin ≥ 8.0 g/dL
  • Normal calcium (corrected for serum albumin)
  • Serum creatinine should be below 2 x ULN
  • In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN.
  • Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range of the central laboratory in patients with well documented Gilbert's Syndrome
  • Life expectancy > 16 weeks

Who cannot join

  • Patient who received vinorelbine in adjuvant setting.
  • Patient with a known hypersensitivity to oral vinorelbine, létrozole, Anastrozole or any of the excipients or others vinca-alcaloïdes. 3. Patient who received any prior anti-cancer therapy (including chemotherapy) for advanced disease with the exception of surgery.
  • Note:
  • Patients who received (neo) adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo) adjuvant setting is permitted if the disease free interval is greater than 24 months from the completion of treatment.
  • Patient has a concurrent malignancy or malignancy within 5 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervix cancer.
  • Patient with known CNS metastases.
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  • Patient with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patient with a known history of HIV infection (testing not mandatory)
  • Patient who any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study (e.g. chronic pancreatitis, chronic active hepatitis, etc.)
  • Patient with active cardiac disease or a history of cardiac dysfunction including any of the following:
  • History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry History of documented congestive heart failure (New York Heart Association functional classification III-IV) Documented cardiomyopathy
  • Patient with peripheral neuropathy>grade 2 CTCAE version 4.0
  • Patient who had major surgery within 14 days prior to starting study drug or has not recovered from major side effects
  • Patient who concurrently using other antineoplastic agents.
  • Patient who has received radiotherapy for palliation ≤ 2 weeks prior to randomization, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia) and/or from whom ≥ 30% of the bone marrow was irradiated.
  • Participation in another clinical trial with any investigational drug within 30 days prior to randomization and/or during the study.
  • Pregnancy or lactating patients
  • Patient with history of surgical resection extended to the stomach or small intestine
  • Patient with a severe infection current or recent (within 2 weeks)
  • Patient needs long-term oxygen therapy
  • Patient with rare hereditary problems of fructose intolerance
  • In combination with the vaccine against yellow fever

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU Besançon

    Besançon

Other trials in France

About this study

Official title: A Randomized Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

This study is designed to evaluate the clinical effects of the addition of metronomic oral vinorelbine to letrozole and anastrozole. The study will compare the efficacy and tolerability of oral metronomic vinorelbine administered in combination with letrozole or anastrozole, as treatment for hormone receptor-positive advanced or metastatic breast cancer without resistance to Aromatase Inhibitors (AI).

Read the detailed description

Letrozole and Anastrozole are AI generally used as the first line of therapy for women with HR+ breast cancer.

Furthermore, present hormonal treatments of advanced breast cancer (ABC) or Metastatic breast cancer (MBC) are sub-optimal, as only approximately one half of patients with oestrogen and/or progesterone receptor positive tumours will respond to therapy.

For this patient population, chemotherapy is a valid option, especially after failure or intolerance to hormone therapy. Both combination and sequential single-agent chemotherapy are reasonable options. Based on the available data, sequential monotherapy is recommended as the preferred choice for MBC. Preferred first-line chemotherapy single agents are anthracyclines, taxanes, capecitabine, gemcitabine and vinorelbine.

The development of oral chemotherapy formulations offer numerous benefits to patients, oncologists, oncology nurses, pharmacists and healthcare providers Metronomic therapy (MT) refers to repetitive, low doses of chemotherapy drugs. MT exerts an effect not only on tumor cells, but also on their microenvironment. In particular, the low-dose schedule compromises the repairing process of endothelial cells, leading to an anti-angiogenic effect. A systematic review of the results of phase I, II and III studies suggests that MT is a treatment option for breast cancer patients, has a low toxicity profile, efficacy in most patients and has potentially significant cost-effective advantages for public health.

Conditions
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.

  • LetrozoleDrug

    Also called FEMARA

    Letrozole 2.5 mg daily

  • AnastrozoleDrug

    Also called ARIMIDEX

    anastrozole 1 mg daily

  • VinorelbineDrug

    Also called Navelbine

    50 mg three times a week (Monday Wednesday and Friday)

Study groups in NCT02730091
Study groupRoleWhat they receive
Letrozole or anastrozoleActive comparatorLetrozole 2,5 mg once a day or anastrozole 1 mg once a day until disease progression, unacceptable toxicity, patient's refusal, consent withdrawal, death, or discontinuation from the study treatment for any other reason.
Receives: Drug: Letrozole; Drug: Anastrozole
Vinorelbine + Anastrozole or letrozoleExperimentalOral vinorelbine 50 mg (1 soft capsule of 30 mg and 1 soft capsule of 20 mg) three times a week every ( Monday, Wednesday and Friday) before lunch and letrozole 2,5 mg once a day or anastrozole 1 mg once a day until disease progression, unacceptable toxicity, patient's refusal, consent withdrawal, death, or discontinuation from the study treatment for any other reason.
Receives: Drug: Letrozole; Drug: Anastrozole; Drug: Vinorelbine

What is being measured

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

  1. progression-free survival (PFS)

    Progression Free Survival is defined as the time from randomization until objective tumor progression or death from any cause if progression did not occur. Subjects will also be considered to have progressed if they have treatment discontinuation with documented evidence of clinical deterioration due to breast cancer. If a patient has not an event, PFS will be censored at the date of the last adequate tumor assessment.

    Measured: up to 5 years

Secondary outcomes (4)

  1. health-related quality of life using HRQoL QLQ-C30 and BR23

    using EORTC QLQ-C30 (targeted dimensions: Global Health, physical and Emotional Dimensions, Fatigue and pain) HRQoL will be considered as the first secondary endpoint in order to confirm clinical benefit for the patient since we need more follow up to observe an impact on overall survival (OS).

    Measured: up to 5 years

  2. overall response rate (ORR)

    ORR and as defined by RECIST 1.1.

    Measured: up to 5 years

  3. clinical benefit rate (CBR)

    CBR, defined as percentage of patients with complete response (CR), partial response (PR) per RECIST or stable disease (SD) lasting 24 weeks or longer

    Measured: up to 5 years

  4. Safety assessed by NCI CTCAE version 4.0",

    using NCI CTCAE version 4.0

    Measured: up to 5 years

Timeline

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

  1. First posted6 Apr 2016 (estimated)
  2. Study start24 Feb 2016
  3. Primary completion23 Mar 2020
  4. Study completion23 Mar 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730091
Sponsor's protocol ID
P/2015/253
Acronym
VICTORIANE
Status last verified
Jan 2021
First submitted
25 Mar 2016
Last updated
1 Feb 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Letrozole, Anastrozole and Vinorelbine in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.

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 22 inclusion and 22 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 1 Feb 2021. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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. 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?

progression-free survival (PFS) (time frame: up to 5 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 NCT02730091.

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 1 Feb 2021.

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