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AzTrials

Breast CancerPhase 2NCT01201265

A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

A Phase 2 study testing Bevacizumab, Carboplatin and Gemcitabine in people with Breast Cancer, run by Hoffmann-La Roche at 12 sites in India.

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

This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Bevacizumab, Carboplatin and Gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
12 sitesIndia
Study dates
Feb 2011to Apr 2015
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Female participants, >/= 18 years of age
  • Metastatic breast cancer
  • Estrogen receptor-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative disease
  • Treatment-naïve for metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate hematological, renal and liver function
  • Patients should have received Anthracyclines and Taxanes in the adjuvant setting
  • Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products

Who cannot join

  • Prior first line treatment for metastatic breast cancer
  • Central nervous system (CNS) metastasis
  • Uncontrolled hypertension (> 170/95 mmHg)
  • Evidence of bleeding diathesis, coagulopathy or hemorrhage at baseline
  • Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
  • Prior therapy with gemcitabine or carboplatin in the metastatic setting. Participants having received gemcitabine or carboplatin as part of adjuvant therapy are eligible, if recurrence was first documented >6 months after the last exposure to the drug(s)
  • Requirement of chronic use of immunosuppressive agents
  • HIV, hepatitis B or hepatitis C infection

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

India12 sites

  • Study site

    Ahmedabad, 380009

  • Study site

    Bangalore, 560029

  • Study site

    Bangalore, 560054

  • Study site

    Delhi, 110029

  • Study site

    Gandhinagar, 382428

  • Study site

    Mumbai, 400012

  • Study site

    Mumbai, 400016

  • Study site

    Mumbai, 400020

  • Study site

    New Delhi, 110011

  • Study site

    New Delhi, 110085

  • Study site

    Pune, 411004

  • Study site

    Vellore, 632004

Other trials in India

About this study

Official title: A Multi Centre, Pilot Phase II Trial Assessing the Efficacy and Safety of Bevacizumab + Gemcitabine + Carboplatin as First Line Treatment for Patients Diagnosed With Triple Negative Metastatic Breast Cancer

This multicenter study will assess the efficacy and safety of bevacizumab in combination with gemcitabine and cisplatin as first line treatment in participants with triple negative metastatic breast cancer. Participants will receive bevacizumab at a dose of 15 mg/kg intravenously (iv) every 3 weeks, plus gemcitabine (1000 mg/m2 iv) and carboplatin (iv to an area under curve [AUC]=2) on Days 1 and 8 of each 3-week cycle. Anticipated time on study treatment is until disease progression.

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.

  • BevacizumabDrug

    Also called Avastin

    15 mg/kg iv every 3 weeks

  • CarboplatinDrug

    to an AUC = 2, on days 1 and 8 of each 3-week cycle

  • GemcitabineDrug

    1000 mg/m2 iv on days 1 and 8 of each 3-week cycle

Study groups in NCT01201265
Study groupRoleWhat they receive
Overall ParticipantsExperimentalParticipants received a combination therapy of bevacizumab with gemcitabine plus carboplatin.
Receives: Drug: Bevacizumab; Drug: Carboplatin; Drug: Gemcitabine

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 (PFS) was calculated in days from the date of registration until the earliest date of documented disease progression or death. The median PFS time with 95% confidence interval (CI) was estimated using Kaplan Meier method. The progression-free survival was assessed utilizing computer tomography (CT)/ magnetic resonance imaging (MRI)/bone scans and X-ray and Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1. Progression of disease is defined as at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.

    Measured: From the date of registration until the disease progression or death (up to 1541 days).

Secondary outcomes (8)

  1. Percentage of Participants Achieving an Overall Response

    The overall response rate (ORR) was defined as complete response (CR) + partial response (PR). ORR was summarized using number and percentage along with two-sided 95% Pearson-Clopper CI. The overall response rate was assessed utilizing the RECIST v. 1.1. CR: disappearance of all target and non-target lesions (TLs) and normalization of tumor markers. Pathological lymph nodes must have short axis measures less than (<) 10 millimeter (mm). PR: at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of TLs, taking as reference the baseline sum of diameters.

    Measured: From the date of registration until the disease progression or death (up to 1541 days)

  2. Percentage of Participants Achieving a Clinical Benefit Response (CBR)

    Clinical benefit response was defined as a complete response (CR), partial response (PR) or stable disease (SD). CBR was assessed using Recist v.1.1. CR: disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

    Measured: From the date of registration until the disease progression or death (up to 1541 days)

  3. Time to Progression (TTP)

    Duration of time to progression (TTP) was estimated using the Kaplan-Meier method. The time to progression was calculated in days from the date of registration until the earliest date of documented disease progression.

    Measured: From the date of registration until the disease progression (up to 1541 days).

  4. Overall Survival (OS)

    Overall survival was measured from the date of the first study drug dose to the date of death from any cause. The median overall survival time with 95%CI was estimated using Kaplan-Meier method.

    Measured: From the date of registration until the disease progression or death (up to 1541 days)

  5. Number of Participants With an Adverse Event (AE)

    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

    Measured: Up to 28 days after termination of study treatment (approximately 1569 days)

  6. Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)

    The EORTC QLQ-C30 (version 3.0) questionnaire incorporates 9 multi scale items: 5 functional scales (physical, role, cognitive, emotional and social); 3 symptom scales (fatigue, pain and nausea \& vomiting); and a global health and quality-of-life scale. It contains 30 questions. The score for each item and the overall score ranges from 0 to 100. A high overall scale and subscale scores represent improved health status. However, in case of symptoms, higher scores suggest increased perception of these symptoms.

    Measured: Baseline, cycle 6

  7. Change From Baseline in Systolic Blood Pressure (SBP)

    Change from baseline in SBP was analyzed by overall response (CR+PR, SD+PD).

    Measured: Baseline, Cycle 6, 12 of treatment

  8. Change From Baseline in Diastolic Blood Pressure (DBP)

    Change from baseline in DBP was analyzed by overall response (CR+PR, SD+PD).

    Measured: Baseline, Cycle 6, 12 of treatment

Timeline

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

  1. First posted14 Sep 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionApr 2015
  4. Study completionApr 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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01201265
Sponsor's protocol ID
ML25420
Status last verified
Apr 2016
First submitted
6 Sep 2010
Last updated
27 May 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Carboplatin and Gemcitabine in people with Breast Cancer, run by Hoffmann-La Roche at 12 sites in India.

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 8 inclusion and 8 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 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in India. 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?

Yes. Results are posted in the registry (first posted 27 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: From the date of registration until the disease progression or death (up to 1541 days).). 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 NCT01201265.

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 27 May 2016.

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