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Breast CancerPhase 3NCT01234337

Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) and Capecitabine in people with Breast Cancer, run by Bayer at 153 sites in 23 countries.

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

The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an… 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?
Sorafenib (Nexavar, BAY43-9006) and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
537 participants
Where
153 sitesin 23 countries
Study dates
21 Feb 2011to 20 Oct 2017
Phase
Phase 3
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

  • Age is >=18 years
  • Subject has histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast. HER2 status should be determined by an accredited laboratory
  • Subject has locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. Must have measurable or non-measurable disease (according to RECIST [Response Evaluation Criteria for Solid Tumors] 1.1)
  • All computer tomography (CT; with contrast) and magnetic resonance imaging (MRI) used to document disease must have been done <= 4 weeks before randomization. Bone scans (if clinically indicated) must have been done <= 12 weeks prior to randomization
  • Subject must have received up to two prior chemotherapy regimens (adjuvant/neo-adjuvant treatments are considered one regimen), and no more than one prior regimen for advanced and/or metastatic disease. Chemotherapy regimens include both targeted and biologic therapy
  • Prior regimens must have included an anthracycline (eg, doxorubicin, epirubicin) and a taxane (eg, paclitaxel, docetaxel), either in combination or in separate regimens, in either the neo-adjuvant/adjuvant or the metastatic setting or both, as either monotherapy or as part of a combination with another agent. Sequential regimens will count as a single regimen; multiple neo-adjuvant / adjuvant regimens will count as a single regimen
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  • Subjects are either resistant to or have failed prior taxane and anthracycline OR Resistant to or have failed prior taxane AND for whom further anthracycline therapy is not indicated (for example, intolerance or cumulative doses of doxorubicin or doxorubicin equivalents [for example, epirubicin)
  • Subjects who relapse beyond 12 months after the last taxane or anthracycline dose given in the adjuvant, neo-adjuvant, or metastatic setting are eligible. Further therapy with the agent(s) for a subsequent regimen must have been considered and ruled out, for example due to prior toxicity or intolerance, or based on the local standard of practice
  • Prior experimental chemotherapy treatment is allowed, provided it is given in combination with at least one drug approved for the treatment of breast cancer (excluding drugs that target VEGF [Vascular Endothelial Growth Factor] or VEGFR [Vascular Endothelial Growth Factor Receptor], eg, bevacizumab, brivanib, sunitinib, vatalinib).
  • Prior hormonal therapy for locally advanced or metastatic breast cancer is allowed. Subjects who are refractory to hormonal therapy are allowed.
  • Prior neo-adjuvant or adjuvant chemotherapy is allowed.
  • Subject must have discontinued prior chemotherapy (including both targeted and biologic therapies), prior therapeutic radiation therapy, or prior hormonal therapy for locally advanced or metastatic disease >= 4 weeks (28 days) before randomization. Start of study treatment is allowed within less than 28 days of the prior therapy provided that 5 half-lives of the prior treatment drug(s) have elapsed
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1
  • Adequate bone marrow, liver and renal function within 7 days prior to randomization
  • All acute toxic effects of any prior treatment have resolved to NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) v4.0 Grade 1 or less
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to randomization
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF (Informed Consent Form) until at least 30 days after the last dose of study drug.
  • Subject must be able to swallow and retain oral medication

Who cannot join

  • HER2 positive breast cancer
  • Unknown hormone receptor status (estrogen and progesterone receptor).
  • Subjects with bilateral breast cancer or a history of two distinct breast cancers.
  • Subjects with inflammatory breast carcinoma.
  • Subjects who have received no prior taxane and anthracycline for the treatment of breast cancer (either in adjuvant, neo-adjuvant or metastatic setting).
  • Prior use of sorafenib or capecitabine
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  • Subjects considered by the treating investigator to be appropriate candidates for hormonal therapy as current treatment for locally advanced/metastatic breast cancer
  • Subjects with locally advanced disease who are considered by the treating investigator to be appropriate candidates for radiation therapy as current treatment for locally advanced breast cancer
  • Subjects with active brain metastases or leptomeningeal disease.
  • Subjects with seizure disorder requiring medication.
  • Radiation to any lesions <= 4 weeks prior to randomization. Palliative radiation to bone metastasis for pain control is permitted with provisions
  • Major surgery, open biopsy, or significant traumatic injury <= 4 weeks
  • Evidence or history of bleeding diathesis or coagulopathy. Uncontrolled hypertension, active or clinically significant cardiac disease. Subject with thrombotic, embolic, venus or arterial events
  • Subjects with any hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or higher within 4 weeks before randomization
  • Subjects with an infection of NCI-CTCAE v4.0 > Grade 2
  • Subjects with a history of human immunodeficiency virus infection or current chronic or active hepatitis B or C infection.
  • Subjects who have used strong CYP3A4 inducers (eg, phenytoin, carbamazepine, phenobarbital, St. John's Wort [Hypericum perforatum], dexamethasone at a dose of greater than 16 mg daily, or rifampin [rifampicin], and/or rifabutin) within 28 days before randomization.
  • Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from breast cancer
  • Subjects with a history DHPD (Dihydropyrimidine dehydrogenase) reaction to fluropyrimidine or history of known or suspected allergy or hypersensitivity to any of the study drugs
  • Presence of a non-healing wound, non-healing ulcer, or bone fracture
  • Women pregnant or breast feeding
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

Trial locations and contacts

153 sites in 23 countries.

153 sites in 23 countries

Spain23 sites

  • Study site

    A Coruña, 15006

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08036

  • Study site

    Castellon, Castellón, 12002

  • Study site

    Lleida, 25198

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28050

  • Study site

    Palma de Mallorca, Illes Baleares, 07120

  • Study site

    Palma de Mallorca, 07198

  • Study site

    Reus, Tarragona, 43204

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Study site

    Seville, 41013

  • Study site

    Seville, 41071

  • Study site

    Terrassa, Barcelona, 08221

  • Study site

    Valencia, 46009

  • Study site

    Valencia, 46010

  • Study site

    Valencia, 46014

Other trials in Spain

United States19 sites

  • Study site

    Albuquerque, New Mexico, 87131

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boston, Massachusetts, 02115-6084

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Burlington, Vermont, 05405

  • Study site

    Durham, North Carolina, 27710

  • Study site

    El Paso, Texas, 79905

  • Study site

    Evansville, Indiana, 47713

  • Study site

    Greenbrae, California, 94904-2007

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Joliet, Illinois, 60435

  • Study site

    Lake Success, New York, 11042

  • Study site

    Louisville, Kentucky, 40207

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Memphis, Tennessee, 38120

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Springfield, Missouri, 65804

  • Study site

    Sylmar, California, 91342

  • Study site

    West Palm Beach, Florida, 33407

Other trials in United States

Italy11 sites

  • Study site

    Ancona, The Marches, 60126

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Cremona, Lombardy, 26100

  • Study site

    Forlì-Cesena, Emilia-Romagna, 47014

  • Study site

    Milan, Lombardy, 20089

  • Study site

    Modena, Emilia-Romagna, 41124

  • Study site

    Monza-Brianza, Lombardy, 20900

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Pisa, Tuscany, 56126

  • Study site

    Ravenna, Emilia-Romagna, 48121

  • Study site

    Rome, Lazio, 00161

Other trials in Italy

Japan11 sites

  • Study site

    Bunkyo, Tokyo, 113-8677

  • Study site

    Chiba, 260-8717

  • Study site

    Fukuoka, 811-1395

  • Study site

    Hidaka, Saitama, 350-1298

  • Study site

    Kagoshima, 892-0833

  • Study site

    Kita-Adachigun, Saitama, 362-0806

  • Study site

    Koto-ku, Tokyo, 135-8550

  • Study site

    Matsuyama, Ehime, 791-0280

  • Study site

    Nagoya, Aichi-ken, 464-8681

  • Study site

    Osaka, 540-0006

  • Study site

    Suita, Osaka, 565-0871

Other trials in Japan

Germany9 sites

  • Study site

    Berlin, 13589

  • Study site

    Cologne, North Rhine-Westphalia, 50931

  • Study site

    Cologne, North Rhine-Westphalia, 51067

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Frankfurt am Main, Hesse, 60389

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Offenbach, Hesse, 63069

  • Study site

    Stendal, Saxony-Anhalt, 39576

Other trials in Germany

Czechia8 sites

  • Study site

    České Budějovice, 370 01

  • Study site

    Nová Ves pod Pleší, 262 04

  • Study site

    Nymburk, 288 02

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 10034

  • Study site

    Prague, 128 08

  • Study site

    Prague, 150 06

  • Study site

    Prague, 150 30

Other trials in Czechia

Australia7 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Bendigo, Victoria, 3550

  • Study site

    Frankston, Victoria

  • Study site

    Garran, Australian Capital Territory, 2605

  • Study site

    Liverpool, New South Wales, 2170

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Waratah, New South Wales, 2298

Other trials in Australia

China7 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100071

  • Study site

    Nanning, 530021

  • Study site

    Shanghai, 200030

  • Study site

    Shenyang, Liaoning, 110001

  • Study site

    Tianjin, 300060

  • Study site

    Xi'an, 710032

Other trials in China

Israel7 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Haifa, 35152

  • Study site

    Jerusalem, 9112001

  • Study site

    Jerusalem, 9372212

  • Study site

    Petah Tikva, 4941492

  • Study site

    Ramat Gan, 5266202

Other trials in Israel

Ireland6 sites

  • Study site

    Cork

  • Study site

    Dublin, 7

  • Study site

    Dublin, 9

  • Study site

    Dublin, DUBLIN 4

  • Study site

    Dublin, DUBLIN 8

  • Study site

    Galway

Other trials in Ireland

Belgium5 sites

  • Study site

    Bruges, 8000

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Edegem, 2650

  • Study site

    Hasselt, 3500

  • Study site

    Liège, Liège, 4000

Other trials in Belgium

France5 sites

  • Study site

    Clermont-Ferrand, 63011

  • Study site

    Lille, 59020

  • Study site

    Nantes, 44805

  • Study site

    Saint-Cloud, 92210

  • Study site

    Toulouse, 31052

Other trials in France

Greece5 sites

  • Study site

    Athens, 11528

  • Study site

    Heraklion, 711 10

  • Study site

    Ioannina, 45500

  • Study site

    Larissa, 41100

  • Study site

    Pátrai, 26500

Other trials in Greece

Hungary5 sites

  • Study site

    Budapest, 1032

  • Study site

    Nyíregyháza, H-4400

  • Study site

    Pécs, 7624

  • Study site

    Szentes, 6600

  • Study site

    Szolnok, H-5004

Other trials in Hungary

South Africa5 sites

  • Study site

    Johannesburg, Gauteng, 2196

  • Study site

    Port Elizabeth, Eastern Cape, 6045

  • Study site

    Pretoria, Gauteng, 0081

  • Study site

    Pretoria, Gauteng, 0084

  • Study site

    Pretoria, Gauteng, 0181

Other trials in South Africa

United Kingdom5 sites

  • Study site

    London, NW3 2QG

  • Study site

    Manchester, M20 4BX

  • Study site

    Northwood, HA6 2RN

  • Study site

    Nottingham, Nottinghamshire, NG5 1PB

  • Study site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Argentina3 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AWC

  • Study site

    Mar del Plata, Buenos Aires, B7600CTO

Other trials in Argentina

Poland3 sites

  • Study site

    Gdansk, 80-952

  • Study site

    Gdynia, 81-519

  • Study site

    Poznan, 61-485

Other trials in Poland

Austria2 sites

  • Study site

    Linz, Upper Austria, 4010

  • Study site

    Vienna, 1100

Other trials in Austria

Canada2 sites

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Montreal, Quebec, H3G 1A4

Other trials in Canada

Russia2 sites

  • Study site

    Chelyabinsk, 454087

  • Study site

    Kazan', 420029

Other trials in Russia

Sweden2 sites

  • Study site

    Stockholm, 118 83

  • Study site

    Stockholm, 171 76

Other trials in Sweden

Puerto Rico1 site

  • Study site

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer

The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.

Read the detailed description

Research summary (NRES, UK):

Breast cancer is the most commonly diagnosed cancer in women and the leading cause of cancer-related death among women worldwide.

However, despite advances in treatment of the early-stage disease, about 25-40% of patients will develop recurrence or spread to other parts of the body that is largely incurable. The average survival of patients with breast cancer that has spread to other parts of the body (metastasis) is 2 to 3 years after diagnosis, and although a number of treatment options are available, including various chemotherapy agents, no single standard of care exists.

The study drug (Sorafenib) works by inhibiting certain pathways in the body that contribute to tumour growth and the formation of new blood vessels (angiogenesis). Angiogenesis plays an important role in the development, transformation and spread of breast cancer. Capecitabine is an approved chemotherapy drug for patients whose breast cancer has spread to other parts of the body (metastatic) and is not responsive to other classes of chemotherapy drugs.

Data from a Phase IIb clinical study suggests that there is a role for the combination of Sorafenib and Capecitabine to treat locally advanced or metastatic breast cancer.

Patients in this confirmatory Phase III study will be randomly assigned to receive either:

  • Capecitabine + Sorafenib
  • Capecitabine + placebo ("dummy medication" with no active drug)

Participants will continue to receive treatments until there is radiographic or clinical progression of disease, side effects which require them to withdraw, pregnancy, protocol non-compliance or withdrawal of consent. Therefore length of participation will vary for individuals. This study is expected to close 31 March 2013.

This is a multicentre study which will take place across Europe, North and South America, Asia, Australia and South Africa. It is anticipated that approximately 519 participants will be recruited worldwide.

Conditions
Breast Cancer
Being tested
Sorafenib (Nexavar, BAY43-9006), Placebo, Capecitabine
Keywords
Breast Cancer, HER2-neu
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Sorafenib (Nexavar, BAY43-9006)Drug

    Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.

  • PlaceboDrug

    Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.

  • CapecitabineDrug

    Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle.days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily,

Study groups in NCT01234337
Study groupRoleWhat they receive
Sorafenib (Nexavar, BAY43-9006) + CapecitabineExperimentalCapecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
Receives: Drug: Sorafenib (Nexavar, BAY43-9006); Drug: Capecitabine
Placebo + CapecitabinePlacebo comparatorCapecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
Receives: 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 (PFS) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1

    PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.

    Measured: From randomization of the first participant until approximately 3 years or until disease radiological progression

Secondary outcomes (5)

  1. Overall Survival (OS)

    OS was defined as the time from date of randomization to death due to any cause. Participants still alive at the time of analysis were censored at their last known alive date. Median and other 95% CIs computed using Kaplan-Meier estimates.

    Measured: From randomization of the first participant until approximately 3 years later

  2. Time to Progression (TTP) by Central Review

    TTP was defined as the time from date of randomization to disease radiological progression by central review. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at least 5 mm. Appearance of new lesions and unequivocal progression of existing non-target lesions was also interpreted as progressive disease. Participants without progression or death at the time of analysis were censored at their last date of evaluable tumor evaluation. Median and other 95% confidence intervals (CIs) computed using Kaplan-Meier estimates.

    Measured: From randomization of the first participant until approximately 3 years later or until disease radiological progression

  3. Objective Response Rate (ORR) by Central Review

    ORR was defined as the best tumor response (Complete Response [CR] or Partial Response [PR]) observed during treatment or within 30 days after termination of study treatment, assessed according to the RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR=CR+PR. CR and PR were confirmed by another scan at least 4 weeks later.

    Measured: From randomization of the first participant until approximately 3 years later or until disease radiological progression

  4. Disease Control Rate (DCR) by Central Review

    DCR was defined as the proportion of participants whose best response was CR, PR, stable disease (SD) or Non-CR/Non-PD. Per RECIST version 1.1, CR=all target lesions disappeared, any pathological lymph node, target/non-target, a reduction in short axis to <10 mm. PR=at least 30% decrease in the sum of diameters of target lesions taking as reference baseline sum diameters. PD=at least 20% increase in the sum of diameters of the target lesions, taking as a reference smallest sum on study. Appearance of new lesions and unequivocal progression of existing non-target lesions. SD=neither sufficient shrinkage qualified for PR nor sufficient increase qualified for PD, taking smallest sum of diameters as a reference. Non-CR/Non-PD=persistence of 1/more non-target lesion(s) and/or maintenance of tumor marker level above normal limits. DCR=CR+PR+SD or Non-CR/Non-PD. CR and PR confirmed by another scan at least 4 weeks later. SD and Non-CR/Non-PD documented at least 6 weeks after randomization.

    Measured: From randomization of the first participant until approximately 3 years later or until disease radiological progression

  5. Duration of Response (DOR) by Central Reader

    DOR was defined as the time from date of first response (CR or PR) to the date when PD is first documented, or to the date of death, whichever occurred first according to RECIST version 1.1. CR=all target lesions disappeared, and any pathological lymph node, whether target or non-target, had a reduction in short axis to <10 mm. If any residual lesion was present, cyto-histology was made available to unequivocally document benignity. PR=at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants still having CR or PR and have not died at the time of analysis were censored at their last date of tumor evaluation. DOR defined for confirmed responders only (that is, CR or PR). 'NA' indicates that value could not be estimated due to censored data. Median and 95% CIs were computed using Kaplan-Meier estimates.

    Measured: From randomization of the first participant until approximately 3 years later or until disease radiological progression

Timeline

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

  1. First posted4 Nov 2010 (estimated)
  2. Study start21 Feb 2011
  3. Primary completion12 May 2014
  4. Study completion20 Oct 2017

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01234337
Sponsor's protocol ID
12444
Other IDs
2010-018501-10
Status last verified
Oct 2018
First submitted
4 Oct 2010
Last updated
6 Nov 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Baselga J, Costa F, Gomez H, Hudis CA, Rapoport B, Roche H, Schwartzberg LS, Petrenciuc O, Shan M, Gradishar WJ. A phase 3 tRial comparing capecitabinE in combination with SorafenIb or pLacebo for treatment of locally advanced or metastatIc HER2-Negative breast CancEr (the RESILIENCE study): study protocol for a randomized controlled trial. Trials. 2013 Jul 22;14:228. doi: 10.1186/1745-6215-14-228.

    PubMed 23876062

  • Baselga J, Zamagni C, Gomez P, Bermejo B, Nagai SE, Melichar B, Chan A, Mangel L, Bergh J, Costa F, Gomez HL, Gradishar WJ, Hudis CA, Rapoport BL, Roche H, Maeda P, Huang L, Meinhardt G, Zhang J, Schwartzberg LS. RESILIENCE: Phase III Randomized, Double-Blind Trial Comparing Sorafenib With Capecitabine Versus Placebo With Capecitabine in Locally Advanced or Metastatic HER2-Negative Breast Cancer. Clin Breast Cancer. 2017 Dec;17(8):585-594.e4. doi: 10.1016/j.clbc.2017.05.006. Epub 2017 May 22.

    PubMed 28830796

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib (Nexavar, BAY43-9006) and Capecitabine in people with Breast Cancer, run by Bayer at 153 sites in 23 countries.

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 18 inclusion and 22 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 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 sites in Spain, United States, Italy, Japan, Germany and 18 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 3 Sep 2015). 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) Assessed by the Independent Review Panel According to Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 (time frame: From randomization of the first participant until approximately 3 years or until disease radiological progression). 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 NCT01234337, which also lists 2 linked publications.

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 6 Nov 2018.

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