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Breast NeoplasmsPhase 2NCT02258464

Study of Radium-223 Dichloride Versus Placebo and Hormonal Treatment as Background Therapy in Subjects With Bone Predominant HER2 (Human Epidermal Growth Factor Receptor 2) Negative Hormone Receptor Positive Metastatic Breast Cancer

A Phase 2 study testing Radium-223 dichloride (Xofigo, BAY88-8223) and Background hormonal therapy in people with Breast Neoplasms, run by Bayer at 71 sites in 20 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Radium-223 dichloride (Xofigo, BAY88-8223) and Background hormonal therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
99 participants
Where
71 sitesin 20 countries
Study dates
2 Mar 2015to 13 Aug 2019
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

  • Documentation of histological or cytological confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast must be available.
  • Women (≥18 years of age) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
  • Documentation of menopausal status: post menopausal or premenopausal subjects are eligible.
  • Subjects with bone dominant disease with at least 2 skeletal metastases identified at baseline by bone scintigraphy and confirmed by CT/magnetic resonance imaging (MRI). Presence of metastases in soft tissue (skin, subcutaneous, muscle, fat, lymph nodes)and/or visceral metastases is allowed.
  • Measurable or non-measurable disease (but radiologically evaluable) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
  • Subjects must have received at least one line of hormonal therapy in the metastatic setting
Show all 11Show fewer
  • Subjects who are eligible for further standard of care endocrine treatment.
  • Subjects enrolled in the current study must start treatment with the single hormone agent either within 15 days prior to randomization or after randomization (before or simultaneously to the first injection of Ra-223/placebo).
  • Subjects must have experienced no more than two skeletal-related events (SREs) prior to study entry defined as: Need for external beam radiotherapy (EBRT) tor bone, pathological bone fracture (excluding major trauma), spinal cord compression and/or orthopedic surgical procedure. Subjects with no prior SREs are not permitted.
  • Subjects must be on therapy with bisphosphonate and denosumab. and are required to have been on such therapy for at least 1 month before start of study treatment.
  • Adequate hematological, liver and kidney function.

Who cannot join

  • Subjects with Inflammatory breast cancer.
  • Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.
  • Subjects with known or history of brain metastases or leptomeningeal disease: subjects with neurological symptoms must undergo a contrast CT scan or MRI of the brain within 28 days prior to randomization to exclude active brain metastasis. Imaging of the central nervous system (CNS) is otherwise not required.
  • Known presence of osteonecrosis of jaw.
  • Patients with immediately life-threatening visceral disease, for whom chemotherapy is the preferred treatment option.
  • Lymphangitic carcinomatosis.
  • Patients with ascites requiring paracentesis within 2 weeks prior to study entry (signature of informed consent) and during the screening period.

Trial locations and contacts

71 sites in 20 countries.

71 sites in 20 countries

United States11 sites

  • Study site

    Ann Arbor, Michigan, 48109

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Bakersfield, California, 93309

  • Study site

    Cedar Rapids, Iowa, 52403

  • Study site

    Houston, Texas, 77230

  • Study site

    La Jolla, California, 92093

  • Study site

    New Haven, Connecticut, 06520

  • Study site

    Pittsburgh, Pennsylvania, 15213-3180

  • Study site

    Pontiac, Michigan, 48341

  • Study site

    St Louis, Missouri, 63110

Other trials in United States

Spain10 sites

  • Study site

    A Coruña, 15009

  • Study site

    Barcelona, 08025

  • Study site

    Barcelona, 08036

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28040

  • Study site

    Madrid, 28041

  • Study site

    Málaga, 29010

  • Study site

    Seville, 41071

  • Study site

    Zaragoza, 50009

Other trials in Spain

Israel8 sites

  • Study site

    Afula, 1834111

  • Study site

    Haifa, 3109601

  • Study site

    Jerusalem, 9103102

  • Study site

    Jerusalem, 9112001

  • Study site

    Kfar Saba, 4428164

  • Study site

    Ramat Gan, 5262000

  • Study site

    Tel Aviv, 64239

  • Study site

    Tsrifin, 7030000

Other trials in Israel

United Kingdom7 sites

  • Study site

    Cottingham, HU16 5JQ

  • Study site

    Merseyside, Merseyside, CH63 4JY

  • Study site

    Northwood, Middlesex, HA6 2RN

  • Study site

    Nottingham, Nottinghamshire, NG5 1PB

  • Study site

    Plymouth, Devon, PL6 8DH

  • Study site

    Sheffield, S10 2SJ

  • Study site

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

South Korea6 sites

  • Study site

    Busan, 49241

  • Study site

    Daegu, 42601

  • Study site

    Incheon

  • Study site

    Seoul, 03080

  • Study site

    Seoul, 05505

  • Study site

    Seoul, 120-752

Other trials in South Korea

Canada4 sites

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Newmarket, Ontario, L3Y 2P9

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Germany3 sites

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Essen, North Rhine-Westphalia, 45147

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Poland3 sites

  • Study site

    Bialystok, 15-027

  • Study site

    Gdynia, 81-519

  • Study site

    Warsaw, 02-781

Other trials in Poland

Austria2 sites

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, Upper Austria, 4020

Other trials in Austria

Czechia2 sites

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 12808

Other trials in Czechia

Denmark2 sites

  • Study site

    Copenhagen, 2100

  • Study site

    Herlev, 2730

Other trials in Denmark

Finland2 sites

  • Study site

    Helsinki, 00290

  • Study site

    Tampere, FIN-33520

Other trials in Finland

France2 sites

  • Study site

    Angers, 49055

  • Study site

    Saint-Cloud, 92210

Other trials in France

Ireland2 sites

  • Study site

    Cork

  • Study site

    Dublin, 7

Other trials in Ireland

Netherlands2 sites

  • Study site

    Nieuwegein, 3435 CM

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Hong Kong1 site

  • Study site

    Kowloon

Other trials in Hong Kong

Norway1 site

  • Study site

    Oslo, 0424

Other trials in Norway

Singapore1 site

  • Study site

    Singapore, 119074

Other trials in Singapore

Switzerland1 site

  • Study site

    Aarau, Canton of Aargau, 5001

Other trials in Switzerland

Taiwan1 site

  • Study site

    Taipei, 11217

Other trials in Taiwan

About this study

Official title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy

The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy

Being tested
Radium-223 dichloride (Xofigo, BAY88-8223), Placebo (saline), Background hormonal therapy
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.

  • Radium-223 dichloride (Xofigo, BAY88-8223)Drug

    Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update)

  • Placebo (saline)Drug

    Up to 6 cycles of saline injection

  • Background hormonal therapyOther

    Prescribed by PI and was provided as long as patient can tolerate treatment. It must be prescribed as per local label in country participating.

Study groups in NCT02258464
Study groupRoleWhat they receive
Radium 223 dichlorideExperimentalParticipants treated with a single hormonal agent as background therapy received 50 kBq/kg body weight (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update) of Radium 223 dichloride intravenously for a maximum of 6 cycles at intervals of 4 weeks
Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Other: Background hormonal therapy
PlaceboPlacebo comparatorParticipants treated with a single hormonal agent as background therapy received isotonic saline (0.9% sodium chloride solution for injection) intravenously for a maximum of 6 cycles at intervals of 4 weeks
Receives: Drug: Placebo (saline); Other: Background hormonal therapy

What is being measured

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

  1. Symptomatic Skeletal Event Free Survival (SSE-FS)

    Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any cause

    Measured: Up to approximately 51 months

Secondary outcomes (8)

  1. Overall Survival

    Time from randomization to death from any cause

    Measured: Up to approximately 51 months

  2. Time to Opiate Use for Cancer Pain

    Interval from the date of randomization to the date of opiate use

    Measured: Up to approximately 51 months

  3. Time to Pain Progression

    Time from randomization to the first date a participants (only in participants with baseline WPS ≤8) experiences pain progression based on worst pain score (WPS) ranging from 0 to 10 and analgesic use. Pain progression is defined as an increase of 2 or more points in the "Worst pain in 24 hours" score from baseline observed at 2 consecutive evaluations ≥4 weeks apart or an increase in pain management (IPM) with respect to baseline, whichever occurs first

    Measured: Up to approximately 51 months

  4. Pain Improvement Rate

    The percentage of participants (baseline WPS>=2) with confirmed pain improvement at any time point. Confirmed pain improvement is defined as a 2 point decrease in worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apart

    Measured: Up to approximately 51 months

  5. Time to Cytotoxic Chemotherapy

    Time from the date of randomization to the date of the first cytotoxic chemotherapy

    Measured: Up to approximately 51 months

  6. Radiological Progression-free Survival (rPFS)

    Time from the date of randomization to the date of first radiological progression or death (if death occurs before progression)

    Measured: Up to approximately 51 months

  7. Number of Participants With Treatment-emergent Adverse Events

    Any event arising or worsening after the start of study drug administration until 30 days after the last study medication intake

    Measured: Up to approximately 7 months

  8. Number of Participants With Post-treatment Adverse Events Including Additional Malignancies and Chemotherapy Related Adverse Events

    AEs related to the study drug, all occurrences of additional malignancies, febrile neutropenia and hemorrhage in subjects receiving chemotherapy, bone fractures and bone associated events (regardless of severity and relationship to study drug), and some symptoms needed for the characterization of an symptomatic skeletal event

    Measured: From 30 days after the last dose of study treatment until the end of study, assessed up to approximately 44 months

Timeline

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

  1. First posted7 Oct 2014 (estimated)
  2. Study start2 Mar 2015
  3. Primary completion13 Aug 2019
  4. Study completion13 Aug 2019

Why it stopped: Due to lower than expected recruitment since the start of study

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02258464
Sponsor's protocol ID
16298
Other IDs
2014-002113-39, 2014
Status last verified
Jul 2020
First submitted
30 Sep 2014
Last updated
10 Aug 2020
Data monitoring committee
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radium-223 dichloride (Xofigo, BAY88-8223) and Background hormonal therapy in people with Breast Neoplasms, run by Bayer at 71 sites in 20 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 11 inclusion and 7 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 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Spain, Israel, United Kingdom, South Korea and 15 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 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 10 Aug 2020). 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?

Symptomatic Skeletal Event Free Survival (SSE-FS) (time frame: Up to approximately 51 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 NCT02258464.

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 10 Aug 2020.

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