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Metastatic Breast CancerPhase 2NCT01416558

Nab-paclitaxel in Metastatic Breast Cancer Patients Failing Solvent Based Taxane (Tiffany)

A Phase 2 study testing Nab-Paclitaxel in people with Metastatic Breast Cancer, run by GBG Forschungs 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

Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes as part of their (neo-)adjuvant therapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Nab-Paclitaxel
Type of treatment
Injection or infusion
How many people
66 participants
Where
1 siteGermany
Study dates
Jul 2011to Oct 2012
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

  • Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.
  • Complete baseline documentation must be submitted via the web-based data collection system MedCODES to the GBG Forschungs GmbH.
  • Diagnosis of locally advanced or metastatic hormone-sensitive or insensitive, HER2-negative or -positive breast cancer.
  • Relapse within ≤ 12 months after completing (last day of last cycle) (neo-) adjuvant chemotherapy.
  • Documented relapse of either a measurable or a non-measurable lesion according to the modified RECIST criteria.
  • Previous neoadjuvant or adjuvant treatment with a solvent based taxane (paclitaxel or docetaxel) irrespective of dose and duration.
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  • Prior endocrine treatment for metastatic / advanced disease is allowed.
  • Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated.
  • Age ≥ 18 years.
  • ECOG Performance Status ≤ 2 (irrespective of restrictions due to breast cancer).
  • Laboratory requirements:Absolute neutrophil count (ANC) >= 1.5 x 109/L., Platelets >= 100 x 109/L., Hemoglobin >= 9 g/dL (>= 5.6 mmol/L)., Prothrombin time (PT) or international normalized ratio (INR) <= 1.2x ULN (upper normal limit), Partial thromboplastin time (PTT) <= 1.2x ULN, Total bilirubin < 1.5x ULN, ASAT (SGOT) and ALAT (SGPT) <= 2.5x ULN (concomitant elevations in serum bilirubin and ASAT/ALAT above 1.0x ULN are not permitted), Creatinine clearance >= 50 mL/min), Urine Protein to Creatinine Ratio (UPC) < 1 (if UPC >= 1, then 24-hour urine protein must be < 1 g).
  • Normal cardiac function confirmed by ECG.
  • A female either of: 1) Non-childbearing potential, i.e. physiologically incapable of becoming pregnant because of history of hysterectomy, bilateral oophorectomy (ovariectomy), bilateral tubal ligation or postmenopausal status.
  • 2) Childbearing potential with a negative pregnancy test (urine or serum)within 2 weeks prior to registration, preferably as close to the first dose as possible, and agrees to use adequate contraception.
  • Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follows:
  • An intrauterine device with a documented failure rate of less than 1% per year, Vasectomised partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female, Complete abstinence from sexual intercourse for 14 days before exposure to the investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product, Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
  • Female subjects who are lactating should discontinue nursing prior to the first dose of study drug and should refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug.

Who cannot join

  • Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances.
  • (Neo-)adjuvant therapy not containing a solvent based taxane.
  • (Neo-)adjuvant therapy with nab-paclitaxel.
  • Concurrent hormonal therapy for cancer.
  • Life expectancy less than 3 months.
  • Pre-existing peripheral neuropathy of > grade 2 (per CTCAE).
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  • Pre-existing grade 3 or 4 diarrhea.
  • Presence of uncontrolled infection.
  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with the subject's safety, provision of informed consent, or compliance to study procedures.
  • Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds during study treatment.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • GBG Forschungs GmbH

    Neu-Isenburg, 63263

Other trials in Germany

About this study

Official title: A Multicenter Non-randomized Phase II Study to Evaluate Nab-paclitaxel in Metastatic Brest Cancer Patients Failing a Solvent Based Taxane as (Neo-)Adjuvant Treatment (Tiffany)

Nab-paclitaxel has demonstrated to be an active agent in breast cancer and probably a less toxic alternative to solvent based taxanes. It is indicated in metastatic breast cancer after failure of anthracyclines. However, most patients receive anthracyclines as well as taxanes as part of their (neo-)adjuvant therapy. There is currently no standard treatment for patients with an early relapse (<12 months) after a taxane containing (neo-)adjuvant therapy. Nab-paclitaxel, a novel nano-particle encapsulated paclitaxel is expected to have only limited cross-resistant to solvent-based taxanes and might therefore be indicated in this setting.

Read the detailed description

Primary Objective:

To determine overall response rate (ORR) and to exclude that it is 20% or lower.

Secondary Objectives:

  1. To determine compliance and toxicity of the therapy.
  2. To determine clinical benefit rate (CBR) in patients with measurable disease.
  3. To determine duration of response.
  4. To determine progression-free survival (PFS).
  5. To determine overall survival.
  6. To assess biomarkers, e.g. SPARC expression in the tissue of the primary or metastatic tumor.
Being tested
Nab-Paclitaxel
Keywords
German Breast Group, GBG Forschungs GmbH, GBG, GBG 65, Tiffany, Breast Cancer, Metastatic Breast Cancer, Nab-Paclitaxel, Abraxane, Taxane Failure
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Nab-PaclitaxelDrug

    Also called Abraxane, EU/1/07/428/001

    Nab-Paclitaxel 125 mg/m2 i.v. over 30 min. weekly in 5 out of 6 weeks

    Given until progression, unacceptable toxicity, patient's request or withdrawal from Study

What is being measured

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

  1. Overall response rate (ORR)

    Measured: 3 years

Secondary outcomes (7)

  1. Toxicity of the therapy

    Number and percent of patients with Adverse Events (any Grade and Grade 3/4).

    Measured: 3 years

  2. Clinical benefit rate (CBR) in patients with measurable disease

    Measured: 3 years

  3. Duration of response

    Measured: 3 years

  4. Progression-free survival (PFS)

    Measured: 3 years

  5. Overall survival (OS)

    Measured: 3 years

  6. SPARC expression rate of the tissue of the primary and/or metastatic tumor

    Measured: 3 years

  7. Compliance of the therapy

    Number and percent of the patients with treatment modifications (dose delay / dose reduction / premature dicontinuation)

    Measured: 3 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 Aug 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionOct 2012
  4. Study completionOct 2012

Why it stopped: Study was terminated because of extrem low recruitment

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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01416558
Sponsor's protocol ID
GBG 65
Other IDs
2011-000075-13
Status last verified
May 2013
First submitted
11 Aug 2011
Last updated
22 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nab-Paclitaxel in people with Metastatic Breast Cancer, run by GBG Forschungs 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 17 inclusion and 10 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 22 May 2013. 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: Study was terminated because of extrem low recruitment). 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?

Overall response rate (ORR) (time frame: 3 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 NCT01416558.

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 22 May 2013.

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