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Breast CancerPhase 2/3BELLE-4NCT01572727

A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation

A Phase 2/3 study testing Paclitaxel and BKM120 in people with Breast Cancer, run by Novartis Pharmaceuticals at 112 sites in 22 countries.

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

This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or 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?
Paclitaxel and BKM120
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
112 sitesin 22 countries
Study dates
Aug 2012to Jun 2015
Phase
Phase 2/3
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Breast cancer that is locally advanced or metastatic
  • HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests)
  • A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
  • Adequate bone marrow and organ function
  • Measurable or non-measurable disease

Who cannot join

  • Prior chemotherapy for locally advanced or metastatic disease
  • Previous treatment with PI3K or AKT inhibitors
  • Patient has symptomatic CNS metastases
  • Concurrent malignancy or malignancy within 3 years of study enrollment
  • Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug
  • Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
Show all 11Show fewer
  • Active heart (cardiac) disease as defined in the protocol
  • Known hypersensitivity or contraindications to use paclitaxel
  • Pregnant or nursing (lactating) woman
  • Certain scores on an anxiety and depression mood questionaire given at screening
  • Other protocol defined criteria may apply

Trial locations and contacts

112 sites in 22 countries.

112 sites in 22 countries

United States21 sites

  • University of New Mexico Cancer Research Center Dept of Univ New Mexico

    Albuquerque, New Mexico, 87131

  • Emory University School of Medicine/Winship Cancer Institute Dept.of WinshipCancerInst. (2)

    Atlanta, Georgia, 30322

  • Ironwood Cancer and Research Centers SC

    Chandler, Arizona, 85224

  • Ohio State Comprehensive Cancer Center/James Cancer Hospital SC-1

    Columbus, Ohio, 43210

  • Baylor Health Care System/Sammons Cancer Center Baylor Texas Oncology

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center Harry Hines

    Dallas, Texas, 75390

  • Highlands Oncology Group Dept of Highlands Oncology Grp

    Fayetteville, Arkansas, 72703

  • California Cancer Care Marian Speciality

    Greenbrae, California, 94904

  • Rocky Mountain Cancer Centers RMCC Hale Pkwy

    Greenwood Village, Colorado

  • University of Kansas Cancer Center Univ Kansas 2

    Kansas City, Kansas, 66160

  • Norton Healthcare, Inc.

    Louisville, Kentucky, 40202

  • Northwest Georgia Oncology Center NW Georgia Onc

    Marietta, Georgia, 30060

  • University of Oklahoma Health Sciences Center OUHSC 2

    Oklahoma City, Oklahoma, 73104

  • University of Nebraska Medical Center Unv Nebraska Med Ctr (2)

    Omaha, Nebraska, 68198

  • Arizona Oncology Associates Dept of Oncology

    Phoenix, Arizona

  • Northwest Cancer Specialists Vancouver Loc

    Portland, Oregon, 97210

  • Medical Oncology & Hematology Associates of Northern VA Med Onc Hem Northern VA

    Reston, Virginia, 20190

  • Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio

    San Antonio, Texas, 78229

  • Washington University School of Medicine Regulatory

    St Louis, Missouri, 63110

  • H. Lee Moffitt Cancer Center & Research Institute SC

    Tampa, Florida, 33612

  • New York Oncology Hematology, P.C. Dept. of New York Oncology. PC

    Troy, New York, 12180

Other trials in United States

Spain15 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15009

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Madrid, Madrid, 28007

  • Novartis Investigative Site

    Madrid, Madrid, 28033

  • Novartis Investigative Site

    Madrid, Madrid, 28034

  • Novartis Investigative Site

    Madrid, Madrid, 28040

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Valencia, Valencia, 46009

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Japan11 sites

  • Novartis Investigative Site

    Isehara, Kanagawa, 259-1193

  • Novartis Investigative Site

    Kawasaki, Kanagawa, 216-8511

  • Novartis Investigative Site

    Koto, Tokyo, 135-8550

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 464-8681

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 467-8602

  • Novartis Investigative Site

    Osaka, Osaka, 537-8511

  • Novartis Investigative Site

    Osaka, Osaka, 540-0006

  • Novartis Investigative Site

    Sapporo, Hokkaido, 135-8550

  • Novartis Investigative Site

    Suita, Osaka, 565-0871

  • Novartis Investigative Site

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

France10 sites

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Créteil, 94010

  • Novartis Investigative Site

    La Roche-sur-Yon, 85925

  • Novartis Investigative Site

    Le Mans, 72015

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Nice, 06189

  • Novartis Investigative Site

    Saint-Herblain, 44805

  • Novartis Investigative Site

    Toulouse, 31059

  • Novartis Investigative Site

    Villejuif, 94805

Other trials in France

Germany9 sites

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Frankfurt, 60389

  • Novartis Investigative Site

    Fulda, 36043

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    München, 80637

  • Novartis Investigative Site

    Ravensburg, 88214

  • Novartis Investigative Site

    Ulm, 89081

Other trials in Germany

Belgium5 sites

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Ottignies, 1340

  • Novartis Investigative Site

    Sint-Niklaas, 9100

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Italy5 sites

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Messina, ME, 98158

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Monza, MB, 20900

Other trials in Italy

Australia4 sites

  • Novartis Investigative Site

    Geelong, Victoria, 3220

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    Parkville, Victoria, 3050

  • Novartis Investigative Site

    Sydney, New South Wales, 2060

Other trials in Australia

Brazil4 sites

  • Novartis Investigative Site

    Fortaleza, Ceará, 60336-045

  • Novartis Investigative Site

    São Paulo, São Paulo, 01221-020

  • Novartis Investigative Site

    São Paulo, São Paulo, 01246-000

  • Novartis Investigative Site

    São Paulo, São Paulo, 01317-002

Other trials in Brazil

United Kingdom4 sites

  • Novartis Investigative Site

    Glasgow - Scotland, G12 OYN

  • Novartis Investigative Site

    London

  • Novartis Investigative Site

    Maidstone, Kent, M16 9QQ

  • Novartis Investigative Site

    Metropolitan Borough of Wirral, CH63 3JY

Other trials in United Kingdom

Czechia3 sites

  • Novartis Investigative Site

    Brno, Czech Republic, 656 53

  • Novartis Investigative Site

    Olomouc, 775 20

  • Novartis Investigative Site

    Prague, 128 08

Other trials in Czechia

Hungary3 sites

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Szolnok, H-5000

Other trials in Hungary

South Korea3 sites

  • Novartis Investigative Site

    Seoul, Korea, 03080

  • Novartis Investigative Site

    Seoul, Korea, 05505

  • Novartis Investigative Site

    Seoul, Korea, 06351

Other trials in South Korea

Taiwan3 sites

  • Novartis Investigative Site

    Kuei-Shan Chiang, Taoyuan/ Taiwan ROC, 33305

  • Novartis Investigative Site

    New Taipei City, 23561

  • Novartis Investigative Site

    Taipei, Taiwan, 10048

Other trials in Taiwan

Austria2 sites

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, A-1090

Other trials in Austria

Israel2 sites

  • Novartis Investigative Site

    Ramat Gan, 5266202

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Netherlands2 sites

  • Novartis Investigative Site

    Breda, Netherlands, 4819 EV

  • Novartis Investigative Site

    Rotterdam, 3075 EA

Other trials in Netherlands

Russia2 sites

  • Novartis Investigative Site

    Saint Petersburg, Russia, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197758

Other trials in Russia

Canada1 site

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1

Other trials in Canada

Hong Kong1 site

  • Novartis Investigative Site

    Hong Kong SAR

Other trials in Hong Kong

Singapore1 site

  • Novartis Investigative Site

    Singapore, Singapore, 119228

Other trials in Singapore

South Africa1 site

  • Novartis Investigative Site

    Johannesburg, 2196

Other trials in South Africa

About this study

Official title: A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.

This study evaluated whether the addition of daily BKM120 to weekly paclitaxel was effective and safe in treating patients with HER2- locally advanced or metastatic breast cancer.

Read the detailed description

Based on the efficacy results at the time of the interim analyses, the DMC recommended stopping the study at Phase II during the interim as it met the protocol pre-specified futility criteria. Consequently, the Phase III portion of the study was not conducted.

Conditions
Breast Cancer
Being tested
Paclitaxel, BKM120 matching placebo, BKM120
Keywords
BKM120, paclitaxel, breast cancer, metastatic, locally advanced, PI3K, PIK3CA, PTEN
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis, Hereditary Sensory and Autonomic Neuropathies

What participants receive

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

  • PaclitaxelDrug

    Also called Taxol

    intravenous paclitaxel 80 mg/m2 per week given until progression

  • BKM120 matching placeboDrug

    Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.

    Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.

  • BKM120Drug

    Also called Buparlisib

    Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.

Study groups in NCT01572727
Study groupRoleWhat they receive
BKM120 and paclitaxelExperimentalAdult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel.
Receives: Drug: Paclitaxel; Drug: BKM120
Placebo and paclitaxelActive comparatorAdult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel.
Receives: Drug: Paclitaxel; Drug: BKM120 matching placebo

What is being measured

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

  1. Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll)

    PFS was defined as the time from the date of randomization to the date of the event, defined as the first radiologically documented disease progression or death due to any cause. Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed

Secondary outcomes (7)

  1. Overall Survival by Kaplan-Meier Estimate (Phase ll)

    Overall survival (OS) was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last contact.

    Measured: every 3 months until death, lost to follow-up, or withdrawal of consent to survival follow-up, up to 10 months after futility was analyzed

  2. Overall Response Rate (Phase ll)

    Percentage of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST v1.1. According to this criteria, CR = at least two determinations of CR at least 4 weeks apart before progression; PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: every 8 weeks after randomization Up to 3 months after end of Treatment

  3. Duration of Response (Phase Lll)

    time from the date of the first documented response (CR or PR, which had to be confirmed subsequently) to the date of the first radiologically documented disease progression or death due to disease

    Measured: every 8 weeks after randomization Up to 3 months after end of Treatment

  4. Time to Response (Phase Lll)

    time from date of randomization until first documented response (CR or PR, which has to be confirmed subsequently).

    Measured: every 8 weeks after randomization Up to 3 months after end of Treatment

  5. Clinical Benefit Rate (CBR) (Phase ll)

    CBR was defined as the percentage of patients with an overall response of CR or PR or SD or non-CR/non-PD lasting more than 24 weeks based on local Investigator's assessment according to RECIST v1.1.

    Measured: every 8 weeks after randomization Up to 3 months after end of Treatment

  6. Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)

    Summary statistics for PK: plasma concentration-time profiles of BKM120 and appropriate individual PK parameters based on population PK model , if deemed appropriate; each cycle = 28 days

    Measured: Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.

  7. Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)

    Time to definitive deterioration of the ECOG performance status from baseline

    Measured: every 4 weeks

Timeline

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

  1. First posted6 Apr 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJun 2015
  4. Study completionJun 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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01572727
Sponsor's protocol ID
CBKM120F2202
Other IDs
2011-005932-24
Acronym
BELLE-4
Status last verified
Jan 2017
First submitted
4 Apr 2012
Last updated
9 Mar 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Paclitaxel and BKM120 in people with Breast Cancer, run by Novartis Pharmaceuticals at 112 sites in 22 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 5 inclusion and 11 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 9 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Spain, Japan, France, Germany and 17 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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 27 Jan 2017). 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 Local Investigator's Assessment (Phase ll) (time frame: Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed). 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 NCT01572727.

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 9 Mar 2017.

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