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Breast CancerPhase 2NCT01690325

Imaging for Response Assessment of Neoadjuvant Chemotherapy in Primary Breast Cancer (GALADON)

A Phase 2 study testing Docetaxel, Trastuzumab and Bevacizumab in people with Breast Cancer, run by Women's Cancer Study Group GmbH at 1 site in Germany.

Terminated

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

Official record
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Trial summary

The GALADON trial is a diagnostic and interventional study in which different molecular imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods (mammography, ultrasound) to see if there can detect… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Docetaxel, Trastuzumab and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteGermany
Study dates
Sep 2012to Nov 2016
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 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Arm A / Arm B
  • Age ≥ 18 years and ≤ 65 years
  • Female
  • Operable, locally advanced primary breast cancer (≥ cT2, N0 or N+, M0) histologically confirmed by core biopsy
  • Histologically confirmed unilateral, solitaire breast cancer
  • Patients who are candidates for neoadjuvant chemotherapy according to AGO guidelines (www.ago-online.de) with unifocal lesion
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  • HER2 positive disease (IHC 3+ and/or FISH positive)or
  • HER2 negative disease (IHC 0/1+, IHC 2+ and/or FISH negative)
  • Baseline LVEF ≥ 55% (measured by MUGA or echocardiography) according to institution specific norm
  • Informed consent for clinical trial including analysis of predictive imaging tests and biomarkers
  • Clinically or by imaging (mammogram, MRI or US) assessed breast cancer ≥ 2 cm or inflammatory breast cancer with bi-dimensional measurable lesion independent of nodal status
  • Negative pregnancy test (urine or serum) within 7 days prior to registration if patient is premenopausal with intact reproductive organs and if patient is less than one year after menopause
  • ECOG Performance status 0-2
  • Adequate organ function for cytotoxic chemotherapy
  • Adequate renal function including Serum creatinine ≤ ULN, Measured or calculated creatinine clearance > 60 ml/min
  • Urine dipstick for proteinuria < 2+. In case of ≥ 2+ proteinuria on dipstick urinalysis, a 24-hour urine collection must be performed and protein per 24 hours must be ≤ 1.0 g
  • Absolute neutrophil count ≥ 1500 cells/μl, platelet count ≥ 100,000 cells/μl
  • Bilirubin ≤ ULN; ALT or AST ≤ 1.5 x ULN, and alkaline phosphatase < 2.5 x ULN
  • Patients must be available and compliant for treatment and follow-up

Who cannot join

  • Arm A / Arm B
  • Evidence of distant metastases by clinical or imaging diagnosis
  • Multifocal primary tumour, defined as histologically confirmed tumour-manifestations within different quadrants; distance ≥ 4 cm
  • Pre-existing motor or sensory neuropathy of a severity ≥ grade 2 NCI criteria
  • Previous breast cancer
  • Prior malignancy with a disease-free survival of < 5 years
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  • Prior malignancy which has not been curatively treated
  • Inflammatory breast cancer without bi-dimensional measurable lesion
  • Prior systemic therapy for cancer
  • Previous therapy with trastuzumab or other anti-HER2 agent (for HER2+ tumors)
  • Previous therapy with bevacizumab or other anti-VEGF agent
  • Patients with immunosuppressive therapy
  • Pregnant or lactating women
  • Women of childbearing potential not using highly effective birth control.
  • Patients with known hypersensitivity reactions to the compounds or incorporated substances of trastuzumab or its constituents (for HER2+ tumors).
  • Patients with known hypersensitivity reactions to the compounds or incorporated substances of bevacizumab or its constituents.
  • Invasive malignancy which could affect compliance with the protocol or interpretation of results.
  • Other serious illness or medical condition including:
  • Known or suspected congestive heart failure (>NYHA I) and/or coronary heart disease
  • Angina pectoris requiring antianginal medication
  • Previous history of myocardial infarction
  • Evidence of transmural infarction on ECG
  • Un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs)
  • Rhythm abnormalities requiring permanent treatment
  • Clinically significant valvular heart disease
  • Patients with dyspnoea at rest due to malignant or other disease or who require supportive oxygen therapy
  • Active serious uncontrolled infections
  • Poorly controlled diabetes
  • History of hypertensive crisis or hypertensive encephalopathy
  • History of TIA or CVA
  • History of any arterial thrombotic event within 12 months before randomization
  • Inadequate bone marrow, hepatic and renal functions as evidenced by the following:
  • Neutrophil count of < 1500, platelet count of < 100,000/µL
  • Haemoglobin < 10 g/dL
  • Serum total bilirubin > ULN (except for patients with clearly documented Gilbert's syndrome)
  • ALT or AST > 1.5 x ULN
  • Alkaline phosphatase > 2.5 x ULN, serum creatinine > ULN
  • Concurrent treatment with any other anti-cancer therapy
  • No informed consent for analysis of predictive imaging tests and biomarkers
  • Contraindications against MRI: Cardiac pacemakers, other forms of medical or biostimulation implants, ferromagnetic foreign bodies or metallic implants (e.g. surgical protheses, aneurysm clips), implanted insulin pumps, valvular implants, allergy to contrast agent, renal insufficiency, claustrophobia
  • Active peptic ulcer, incomplete wound healing or unhealed bone fracture
  • Previous thromboembolic events, known hemorrhagic diathesis, coagulopathy with increased bleeding risk, or treatment with anticoagulants. Current or recent (within 10 days of first dose of bevacizumab) use of acetalic acid (> 325 mg/day) or clopidogrel (> 75 mg/day)
  • Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel, ulcerative colitis; abdominal fistula, intra-abdominal abscess within 6 months of enrolment or gastrointestinal perforation
  • Major surgery within the last 28 days or anticipation of the need for major surgery during study treatment with bevacizumab. No minor surgeries including insertion of an indwelling catheter within 24h prior to registration.
  • Concurrent treatment with other experimental drugs; participation in another clinical trial with any investigational drug within 30 days prior to study entry
  • Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
  • Patients with a history of hypersensitivity reaction to docetaxel or to drugs formulated with polysorbate 80

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Breast Centre, University of Munich, LMU

    Munich, Bavaria, 81377

Other trials in Germany

About this study

Official title: Molecular Imaging for Response Assessment of Bevacizumab + Docetaxel as Neoadjuvant Chemotherapy in Primary Breast Cancer

The GALADON trial is a diagnostic and interventional study in which different molecular imaging methods as Positon Emission Tomography (PET), different kind of Magnetic Resonance Imaging - methods (MRI, DWI and DCE-MRI) will be compared with common imaging methods (mammography, ultrasound) to see if there can detect an early response to a combined neoadjuvant therapy with bevacizumab and docetaxel in patients with locally advanced breast cancer. Neoadjuvant chemotherapy (this means patients were treated before the tumor was removed by surgery) with a drug like trastuzumab (monoclonal antibody) which is target to the Her2-protein is much more powerful than with chemotherapy alone because it is normalizing the blood supply and improves tumor delivery of conventional chemotherapy like docetaxel. The HER2 protein is only available in about 30 % of breast cancer types. bevacizumab is another humanized monoclonal antibody like trastuzumab but is effective not only in patients with an positive HER2 status and in combination with trastuzumab it may emphasize the effect in reduction of tumor growth. Bevacizumab is approved in advanced disease, but no major neoadjuvant data available so far for primary breast cancer. As the therapy with monoclonal antibody regimes are expensive and may cause severe side effects predictive factors to select patients who will benefit from such highly specific drugs before therapy start would be medically and economically highly valuable. In this study the efficacy of combined neoadjuvant chemotherapy with bevacizumab, trastuzumab and docetaxel in Arm A and bevacizumab and docetaxel in Arm B should be evaluated and the predictive impact of different imaging methods for tumor response should be shown.

Conditions
Breast Cancer
Being tested
Docetaxel, Trastuzumab, Bevacizumab, Epirubicin, Cyclophosphamid
Keywords
Neoadjuvant chemotherapy, Neoadjuvant cytotoxic-antiangiogenic therapy, Bevacizumab, PET
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT01690325
Study groupRoleWhat they receive
Docetaxel, Avastin, Herceptin; adjuv. Epirubicin, Cyclophos.ExperimentalArm A: Neoadjuvant: 6 cycles of Docetaxel every 21 days together with 6 cycles of Avastin and Herceptin; Adjuvant: 4 cycles of Epirubicin and Cyclophosphamid every 21 days together with 12 cycles of Herceptin every 21 days.
Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: Bevacizumab; Drug: Epirubicin; Drug: Cyclophosphamid
Docetaxel, Avastin; adjuvant Epirubicin, CyclophosphamidExperimentalArm B: neoadjuvant: 6 cycles of Docetaxel and Avastin every 21 days. Adjuvant: 4 cycles of Epirubicin and Cyclophosphamid every 21 days.
Receives: Drug: Docetaxel; Drug: Bevacizumab; Drug: Epirubicin; Drug: Cyclophosphamid

What is being measured

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

  1. Rate of pathological complete response (pCR) following neoadjuvant therapy in group A and group B

    To determine efficacy of cytotoxic-antiangiogenic neoadjuvant therapy in primary breast cancer: bevacizumab+trastuzumab+docetaxel fro group A (HER2 positive) or bevacizumab+docetaxel for group B (HER2 negative) using pathological complete response (pCR) as the primary endpoint.

    Measured: about 18 weeks (start of neoadjuvant chemotherapy until surgery)

Timeline

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

  1. First posted21 Sep 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionNov 2016
  4. Study completionNov 2016

Why it stopped: Therapy of HER2+ patients according to protocol was no longer appropriate. Patient enrolment behind planned schedule and challenges of site performance

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01690325
Sponsor's protocol ID
WSG-AM05
Status last verified
Aug 2018
First submitted
18 Sep 2012
Last updated
13 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Trastuzumab and Bevacizumab in people with Breast Cancer, run by Women's Cancer Study Group GmbH at 1 site in Germany.

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 47 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 13 Aug 2018. 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 Germany. 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: Therapy of HER2+ patients according to protocol was no longer appropriate. Patient enrolment behind planned schedule and challenges of site performance). 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?

Rate of pathological complete response (pCR) following neoadjuvant therapy in group A and group B (time frame: about 18 weeks (start of neoadjuvant chemotherapy until surgery)). 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 NCT01690325.

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 13 Aug 2018.

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