AzTrials
AzTrials

Breast CancerPhase 2NCT00493636

1st or 2nd Line MBC (Metastatic Breast Cancer) With Previous Avastin (Bevacizumab) Therapy

A Phase 2 study testing Gemcitabine, Sorafenib and Capecitabine in people with Breast Cancer, run by Accelerated Community Oncology Research Network at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study is being conducted to compare progression-free survival in patients treated with sorafenib and gemcitabine/capecitabine versus patients treated with placebo and gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed during or following treatment with a… 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?
Gemcitabine, Sorafenib and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
160 participants
Where
44 sitesUnited States
Study dates
Jun 2007to Nov 2012
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of the breast.
  • Measurable or evaluable locally advanced or metastatic disease.
  • Age ≥18 years.
  • Disease progression during or after treatment with a bevacizumab-containing regimen in the adjuvant or first-line metastatic setting.
  • Patients must have discontinued chemotherapy at least 3 weeks prior to randomization.
  • No more than one prior chemotherapy regimen for locally advanced or metastatic disease.
Show all 13Show fewer
  • Prior hormonal therapy allowed provided it has been discontinued prior to randomization.
  • Prior radiation therapy is allowed but must be completed at least 3 weeks prior to randomization. Previously radiated area(s) must not be the only site of disease.
  • ECOG Performance Status of 0 or 1.
  • Adequate bone marrow, liver, and renal function
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization, and must agree to use adequate contraception prior to study entry, for the duration of study participation and 28 days after the last study drug dosing.
  • Patients must be able and willing to sign a written informed consent.
  • Patients must be able to swallow and retain oral medication.

Who cannot join

  • Patients with breast cancer over-expressing human epidermal growth factor receptor 2 (HER-2) (gene amplification by FISH or 3+ over-expression by immunohistochemistry). Patients with unknown HER-2 status are not eligible.
  • Patients with active brain metastases.
  • Major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
  • Prior use of gemcitabine/capecitabine or sorafenib.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Serious, non-healing wound, ulcer, or bone fracture.
Show all 24Show fewer
  • Substance abuse, or medical, psychological, or social condition that may interfere with the patient's participation in the study or evaluation of the study results.
  • Use of cytochrome P450 enzyme-inducing anti-epileptic drugs is not allowed.
  • Clinically significant cardiac disease
  • Uncontrolled hypertension
  • Thrombolic, embolic, venous, or arterial events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event > NCI-CTCAE Grade 2 within 4 weeks of randomization.
  • Any other hemorrhage/bleeding event ≥ NCI-CTCAE Grade 3 within 4 weeks of randomization.
  • Active clinically serious infection > NCI-CTCAE Grade 2.
  • Known HIV infection or chronic hepatitis B or C (the safety and effectiveness of sorafenib in this patient population have not been studied).
  • Previous or concurrent cancer that is distinct in primary site or histology from breast cancer EXCEPT cervical cancer in-situ, treated basal cell carcinoma, superficial bladder tumors [Ta and Tis] or any cancer curatively treated > 5 years prior to randomization.
  • Known or suspected allergy to sorafenib or gemcitabine/capecitabine.
  • Prior or concurrent use of St. John's Wort or rifampin (rifampicin) within 3 weeks of randomization.
  • Concurrent anti-cancer therapy other than gemcitabine/capecitabine and sorafenib/placebo.
  • Prior treatment with any agent that targets VEGF or VEGFR (licensed or investigational), except bevacizumab.
  • Women who are pregnant or breast-feeding.
  • Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding randomization.
  • Inability to comply with protocol and/or not willing or not available for follow-up assessments.
  • Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Providence Cancer Center / Katmai Oncology Group LLC

    Anchorage, Alaska, 99508

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48105

  • Augusta Oncology Associates, PC

    Augusta, Georgia, 30901

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Pasco Hernando Oncology Associates PA

    Brooksville, Florida, 34613

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29403

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • Northwestern University-Robert H. Lurie Comprehensive Cancer Center

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Compassionate Cancer Care-Corona

    Corona, California, 92879

  • Oncology Hematology Specialists, PA

    Denville, New Jersey, 07134

  • Hematology Oncology of Northeast Pennsylvania

    Dunmore, Pennsylvania, 18512

  • Hematology Oncology Associates of New York

    East Syracuse, New York, 13057

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80528

  • Compassionate Cancer Care-Fountain Valley

    Fountain Valley, California, 92879

  • Oncology Alliance

    Glendale, Wisconsin, 53212

  • California Cancer Care

    Greenbrae, California, 94904-2007

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Queens Cancer Center

    Jamaica, New York, 11432

  • Columbia Comprehensive Cancer Care Clinic & Research Institute

    Jefferson City, Missouri, 65109

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Cascade Cancer Center

    Macon, Georgia, 31201

  • Central Georgia Cancer Care

    Macon, Georgia, 31201

  • Northwest Georgia Oncology Center

    Marietta, Georgia, 30060

  • The West Clinic

    Memphis, Tennessee, 38120

  • Pasco Hernando Oncology Associates PA

    New Port Richey, Florida, 34652

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Pennsylvania Oncology Hematology Associates

    Philadelphia, Pennsylvania, 19106

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Compassionate Cancer Care-Riverside

    Riverside, California, 92501

  • Sutter Cancer Center

    Sacramento, California, 98516

  • California Pacific Medical Center

    San Francisco, California, 94107

  • University of California San Francisco Comprehensive Cancer Center

    San Francisco, California, 94115

  • North Coast Cancer Care

    Sandusky, Ohio, 44870

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04474-9308

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46601

  • Baystate Medical Center

    Springfield, Massachusetts, 01107

  • Hematology Oncology PC / Bennett Cancer Center

    Stamford, Connecticut, 06902

  • Oncology Associates of Bridgeport

    Trumbull, Connecticut, 06611

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: A Double-Blind, Randomized Phase 2b Study of Sorafenib Compared to Placebo When Administered in Combination With Chemotherapy for Patients With Locally Advanced or MBC That Has Progressed During or After Bevacizumab Therapy

The study is being conducted to compare progression-free survival in patients treated with sorafenib and gemcitabine/capecitabine versus patients treated with placebo and gemcitabine/capecitabine for locally advanced or metastatic breast cancer that has progressed during or following treatment with a bevacizumab-containing regimen.

Conditions
Breast Cancer
Being tested
Gemcitabine, Sorafenib, Placebo, Capecitabine
Keywords
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.

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle

  • SorafenibDrug

    Also called Nexavar

    Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

  • PlaceboDrug

    Also called Sugar pill

    Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)

  • CapecitabineDrug

    Also called Xeloda

    Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine).

Study groups in NCT00493636
Study groupRoleWhat they receive
A (Sorafenib + Gemcitabine or Capecitabine)Active comparatorSorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Receives: Drug: Gemcitabine; Drug: Sorafenib; Drug: Capecitabine
B (Placebo + Gemcitabine or Capecitabine)Placebo comparatorPlacebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)
Receives: Drug: Gemcitabine; Drug: Placebo; Drug: Capecitabine

What is being measured

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

  1. Progression Free Survival

    Measured: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.

Secondary outcomes (4)

  1. Overall Survival

    Measured: From the date of randomization to date of death due to any cause, assessed up to 56 months.

  2. Time to Progression

    Measured: Calculated as the time (days) from date of randomization to date of first observed disease progression (radiological or clinical, whichever is earlier), assessed up to 39 months.

  3. Overall Response Rate

    Overall response rate was defined as the proportion of participants experiencing complete response (CR) and partial response (PR) as best overall response. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.

    Measured: The overall tumor burden at baseline will be compared with subsequent measurements up to the date of first documented disease progression or the date of death due to any cause, if before progression, assessed up to 39 months.

  4. Duration of Overall Response

    Duration of overall response was calculated as the time (days) from first documentation of CR or PR (whichever status is recorded first) until the first date that recurrent or progressive disease (PD) or death is objectively documented. Response was evaluated via changes from baseline in radiological tumor measurements using RECIST version 1.0 guidelines, where complete response (CR) is the disappearance of all target lesions; partial response (PR) is >=30% decrease in the sum of the longest diameter (LD) of target lesions; Stable Disease (SD) is neither sufficient shrinkage in sum of LD of target lesions to be PR nor increase of >=20%; Progressive Disease (PD) is the increase in existing lesions or new lesions.

    Measured: Period measured from the first documentation of complete or partial response (whichever status is recorded first) until the first date that recurrent or progressive disease or death is objectively documented.

Timeline

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

  1. First posted28 Jun 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionSep 2010
  4. Study completionNov 2012

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00493636
Sponsor's protocol ID
ACORN AC01B07
Status last verified
May 2014
First submitted
26 Jun 2007
Last updated
20 May 2014
Data monitoring committee
Yes

Publications

  • Schwartzberg LS, Tauer KW, Hermann RC, Makari-Judson G, Isaacs C, Beck JT, Kaklamani V, Stepanski EJ, Rugo HS, Wang W, Bell-McGuinn K, Kirshner JJ, Eisenberg P, Emanuelson R, Keaton M, Levine E, Medgyesy DC, Qamar R, Starr A, Ro SK, Lokker NA, Hudis CA. Sorafenib or placebo with either gemcitabine or capecitabine in patients with HER-2-negative advanced breast cancer that progressed during or after bevacizumab. Clin Cancer Res. 2013 May 15;19(10):2745-54. doi: 10.1158/1078-0432.CCR-12-3177. Epub 2013 Feb 26.

    PubMed 23444220

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gemcitabine, Sorafenib and Capecitabine in people with Breast Cancer, run by Accelerated Community Oncology Research Network at 44 sites in United States.

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 13 inclusion and 24 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States. 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. Some participants in this study may receive a placebo. 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 16 May 2014). 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 (time frame: From the date of randomization to date of first documented disease progression (i.e., the date on which a radiologic procedure or clinical evaluation was performed) or the date of death due to any cause, if before progression, assessed up to 39 months.). 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 NCT00493636, which also lists 1 linked publication.

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 20 May 2014.

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