AzTrials
AzTrials

Breast CancerPhase 2NCT01985841

Bevacizumab in Combination With Chemotherapy in the Neo-adjuvant Setting for HER2 (-) Breast Cancer

A Phase 2 study testing Bevacizumb, 5-Fluorouracil and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 6 sites in Greece.

Terminated

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

Official record
Search all trials

Trial summary

Investigators propose to study the efficacy of Bevacizumab plus systemic chemotherapy prior to surgery in order to make a locally advanced tumor operable. Treatment is thus expected to induce a maximum tumor shrinkage within a short period (usually 3-6 months). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Breast Cancer
What is being tested?
Bevacizumb, 5-Fluorouracil and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
6 sitesGreece
Study dates
Oct 2011to Apr 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients with histologic proven, corebiopsied, invasive ductal adenocarcinoma of the breast >2 cm in size and of any N stage (clinical and/or radiological T-stage > T1, including T4d), scheduled to receive preoperative chemotherapy.
  • Age 18-70 years
  • ECOG performance-status ≤1
  • No prior or current neoplasm except for curatively treated non melanoma skin cancer, in situ carcinoma of the cervix
  • No distant disease/secondary carcinoma
  • Normal cardiac function
Show all 19Show fewer
  • Results of the following assessments at the time of inclusion must be available:
  • bilateral Mammography (before enrolment)
  • histology
  • grading
  • hormone-receptor-status
  • HER2 status negative (is defined as FISH/CISH negative or IHC0 or IHC1+, or IHC2+ and FISH/CISH negative)
  • Laboratory requirements (within 1 week before enrolment):
  • Hematology: Neutrophils ≥ 1.5 x 109/l, Platelets ≥ 100 x 109/l, Hemoglobin>11 g/dl
  • Hepatic function: Total bilirubin < 1 x ULN, SGOT and SGPT < 1.5 x ULN, Alkaline phosphatases < 1.5 x ULN. In case of abnormal values, the liver function tests have to be repeated within 3 days before study treatment.
  • Renal function: Creatinine < 1 x ULN
  • Urinalysis: Urine dipstick of proteinuria < 2+. Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate <1 g of protein / 24 hours.
  • Signed and dated Informed Consent before the start of specific protocol procedures
  • If of childbearing potential, negative pregnancy test

Who cannot join

  • Cytological only confirmation of diagnosis
  • Lobular or other non-ductal types of breast cancer
  • Pregnant, or lactating patients; patients of childbearing potential must implement adequate contraceptive measures during study participation
  • Pre-existing motor or sensory neurotoxicity of a severity > grade 2 by NCI-CTC AE
  • Preoperative local treatment for breast cancer (i.e. incomplete surgery, radiotherapy)
  • Prior or concurrent systemic antitumor therapy
Show all 17Show fewer
  • Evidence of wound healing complications, bone fracture, ulcer or the presence of clinically significant peripheral vascular disease
  • Clinically significant cardiac disease e.g. congestive heart failure.
  • Other serious illness or medical condition-uncontrolled hypertension or high risk uncontrolled arrythmias -history of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent-active uncontrolled infection-unstable peptic ulcer, unstable diabetes mellitus or other contraindication for the use of corticosteroids
  • Known hypersensitivity reaction to the compounds or incorporated substances.
  • Evidence of bleeding diathesis or coagulopathy
  • The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or appropriate monitoring test is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of randomization. Patients not receiving anti coagulant medication must have an INR ≤ 1.5 an aPTT ≤ 1.5 x ULN within 7 days of randomization.
  • Ongoing treatment with aspirin (> 325mg / day) or other medications known to predispose to gastrointestinal ulceration.
  • Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment.
  • Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion
  • Treatment with an investigational drug within 30 days prior to study entry.
  • Legally incapacitated and/or other circumstances which make it undesirable for the subject to understand the nature, meaning and consequences of the clinical study

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Greece6 sites

  • "IASO" General Hospital of Athens

    Athens

  • Air Forces Military Hospital of Athens

    Athens

  • University Hospital of Crete, Dep of Medical Oncology Heraklion, Greece

    Heraklion

  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

    Piraeus

  • "Euromedica" Hospital of Thessaloniki

    Thessaloniki

  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

    Thessaloniki

Other trials in Greece

About this study

Official title: Phase II, Open-label Non-randomized Trial to Investigate the Efficacy of Bevacizumab in Combination With Dose Dense Sequential Chemotherapy in the Neo-adjuvant Setting for HER2 Negative Breast Cancer Patients

Investigators propose to study the efficacy of Bevacizumab plus systemic chemotherapy prior to surgery in order to make a locally advanced tumor operable. Treatment is thus expected to induce a maximum tumor shrinkage within a short period (usually 3-6 months). In addition Bevacizumab (Avastin) is to be administered as early as possible during the disease stages. The primary aim of this study is to evaluate the preliminary antitumor activity in terms of pathological complete responses (pCR) of bevacizumab in combination with chemotherapy.

Read the detailed description

The aim of administering systemic therapy prior to surgery is to make a locally advanced tumor operable or to allow conservative surgery in the case of a T2-T3 tumor. Therefore, treatment is expected to induce a maximum tumor shrinkage within a short period. In addition and based on the anti-angiogenic MoA, bevacizumab (Avastin) is to be administered as early as possible during the disease stages. Bevacizumab has already been tested in the neoadjuvant setting with encouraging results. In a first trial patients with inoperable locally advanced breast cancer received docetaxel with or without bevacizumab with five clinical Complete Responses and 24 Partial Responses. In a second trial there was also reported the results of the combination of bevacizumab with doxorubicin and docetaxel for the treatment of inflammatory breast cancer. Then, a set of studies of primary therapy exploring the activity of different regimens have confirmed the role of baseline pathological features of the tumor in predicting the responsiveness to primary therapy. A 22% pathological complete responses (pCR) rate has been achieved in a study combining bevacizumab together with Xeloda and Taxotere suggesting that bevacizumab addition to chemotherapy in the neoadjuvant treatment is feasible showing promising activity while no unexpected toxicities were reported.

Thus, a very high interest exists from our clinicians mostly within our cooperative groups which cover the largest national oncology centers to be involved and run such a study.

Conditions
Breast Cancer
Keywords
Early breast cancer, Primary operable breast cancer, HER2- negative, bevacizumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • BevacizumbDrug

    Also called Bevacizumab: 10 mg/kg for up to 8 cycles from date of first dose, (cycle repeated every two weeks)

    Avastin

  • 5-FluorouracilDrug

    Also called 5-Fluorouracil: 700mg/m2 for up to 4 cycles from date of first dose, (cycle repeated every two weeks)

    5-FU

  • EpirubicinDrug

    Also called Epirubicin: 75mg/m2 for up to 4 cycles from date of first dose, (cycle repeated every two weeks)

    Farmorubicin

  • CyclophosphamideDrug

    Also called Cyclophosphamide: 700mg/m2 for up to 4 cycles from date of first dose, (cycle repeated every two weeks)

    Endoxan

  • DocetaxelDrug

    Also called Docetaxel: 75mg/m2 for up to 4 cycles from date of first dose, (cycle repeated every two weeks)

    Taxotere

Study groups in NCT01985841
Study groupRoleWhat they receive
Bevacizumab/FEC/DocetaxelExperimentalBevacizumab plus 5-Fluorouracil/Epirubicin/Cyclophosphamide (FEC) -> Bevacizumab plus Docetaxel
Receives: Drug: Bevacizumb; Drug: 5-Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel

What is being measured

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

  1. Number of Patients with Complete Response

    Patients will be assessed for tumor response on week 8 and on week 16. Patients with tumor reduction will proceed on surgery. Histology report will confirm the complete or partial responses to chemotherapy.

    Measured: On week 8 and 16

Secondary outcomes (2)

  1. Overall Survival

    Patients overall survival will be calculated from the date of the first chemotherapy cycle until the date of death from any cause

    Measured: 3 years

  2. Progression Free Survival

    Patients will be assessed every 8 weeks, from date of randomization until the end of treatment and then every 3 months until the date of first documented disease progression or date of death from any cause, whichever came first, up to 260 weeks (65 months).

    Measured: 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 posted15 Nov 2013 (estimated)
  2. Study startOct 2011
  3. Primary completionApr 2015
  4. Study completionApr 2015

Why it stopped: Due to poor accrual

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01985841
Sponsor's protocol ID
CT/10.15
Status last verified
Oct 2015
First submitted
13 Sep 2013
Last updated
8 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumb, 5-Fluorouracil and Epirubicin in people with Breast Cancer, run by Hellenic Oncology Research Group at 6 sites in Greece.

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 19 inclusion and 17 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 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Greece. 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 was stopped early (reason given: Due to poor accrual). 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?

Number of Patients with Complete Response (time frame: On week 8 and 16). 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 NCT01985841.

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 8 Oct 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in