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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02340221




Registration number
NCT02340221
Ethics application status
Date submitted
13/01/2015
Date registered
16/01/2015
Date last updated
11/06/2020

Titles & IDs
Public title
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Scientific title
A Phase III, Double-Blind, Placebo-Controlled, Randomized Study of Taselisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Locally Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
Secondary ID [1] 0 0
2014-003185-25
Secondary ID [2] 0 0
GO29058
Universal Trial Number (UTN)
Trial acronym
SANDPIPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Taselisib
Treatment: Drugs - Placebo
Treatment: Drugs - Fulvestrant

Experimental: Taselisib + Fulvestrant - Participants received taselisib 4 milligrams (mg) taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.

Placebo Comparator: Placebo + Fulvestrant - Participants received placebo taken orally once daily (QD) beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by intramuscular (IM) injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.


Treatment: Drugs: Taselisib
Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.

Treatment: Drugs: Placebo
Placebo matching to taselisib was administered as per the schedule specified in the respective arm.

Treatment: Drugs: Fulvestrant
Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) - PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Timepoint [1] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response (Partial Response [PR] Plus Complete Response [CR]), as Assessed Using RECIST v.1.1 - PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions).
Timepoint [1] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [2] 0 0
Overall Survival (OS) - OS was defined as the time from the date of randomization to the date of death due to any cause.
Timepoint [2] 0 0
From randomization up to death from any cause (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [3] 0 0
Percentage of Participants With Clinical Benefit, as Assessed According to RECIST v1.1 - Clinical benefit was defined as objective response (PR+CR), or no disease progression lasting for more than or equal to (>/=) 24 weeks since randomization. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Timepoint [3] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [4] 0 0
Duration of Objective Response, as Assessed by Investigator Using RECIST v1.1 - Duration of objective response: the time from the first tumor assessment that supported the participant's objective response (CR or PR, whichever was first recorded) to first documented disease progression or death due to any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels (as applicable to non-target lesions). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Timepoint [4] 0 0
Time from the first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [5] 0 0
PFS as Assessed by Blinded Independent Central Review (BICR) Using RECIST v1.1 - PFS was defined as the time from randomization to disease progression as determined by BICR with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.
Timepoint [5] 0 0
From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years)
Secondary outcome [6] 0 0
Percentage of Participants With Adverse Events - An adverse event was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Timepoint [6] 0 0
From randomization up to the 15 Oct 2017 data cutoff, approximately 2.5 years.
Secondary outcome [7] 0 0
Maximum Observed Plasma Concentration (Cmax) of Taselisib
Timepoint [7] 0 0
1 to 4 hours (hrs) post-dose on Cycle (C) 1, Day (D) 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1 (each cycle=28 days)
Secondary outcome [8] 0 0
Minimum Observed Plasma Concentration (Cmin) of Taselisib
Timepoint [8] 0 0
1 to 4 hrs post-dose on Cycle 1, Day 1; 0 to 3 hrs pre-dose and 2 to 6 hrs post dose on Cycle 2, Day 1; 0 to 3 hrs pre-dose on Cycle 6, Day 1 (each cycle=28 days)
Secondary outcome [9] 0 0
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Score - The EORTC QLQ-C30 consists of 30 questions that comprise aspects of participant's functioning assessment (physical, emotional, role, cognitive, and social); symptom scales (fatigue; nausea, vomiting, and pain; the global health/quality of life [QoL]); and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties), within a recall period of "the past week." Most questions used a 4-point scale (1=Not at all to 4=Very much; two questions used a 7-point scale (1=Very poor to 7=Excellent). Scores were averaged and transformed to a 0-100 scale; a higher score for Global Qol/functional scales=better level of functioning; a higher score for symptom scale=greater degree of symptoms.
Timepoint [9] 0 0
Baseline, C2D1 up to C7D1 (each cycle=28 days)
Secondary outcome [10] 0 0
Change From Baseline in Modified EORTC Quality of Life Questionnaire Breast Cancer Module 23 (QLQ-BR23) Score - EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30 and consists of functional scales (body image, sexual enjoyment, sexual functioning, future perspective [FP]) and symptom scales (systemic side effects [SE], upset by hair loss, arm symptoms, breast symptoms). Questions used a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores were averaged and transformed to a 0-100 scale. Higher scores for the functional scales indicated a higher/better level of functioning/healthy functioning. Higher scores for the symptom scales indicated worse symptoms.
Timepoint [10] 0 0
Baseline, C2D1 up to C7D1 (each cycle=28 days)

Eligibility
Key inclusion criteria
- Postmenopausal women with histologically or cytologically confirmed locally advanced
or metastatic estrogen receptor (ER) positive breast cancer

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Participants for whom endocrine therapy (example [e.g.], fulvestrant) is recommended
and treatment with cytotoxic chemotherapy is not indicated at time of entry into the
study

- Radiologic/objective evidence of recurrence or progression to the most recent systemic
therapy for breast cancer

- Radiologic/objective evidence of breast cancer recurrence or progression while on or
within 12 months of the end of adjuvant treatment with an aromatase inhibitor (AI), or
progression while on or within 1 month of the end of prior AI treatment for locally
advanced or metastatic breast cancer

- Measurable disease via Response Evaluation Criteria in Solid Tumors (RECIST) Version
1.1 (v1.1) or non-measurable, evaluable disease with at least one evaluable bone
lesion via RECIST v1.1

- Consent to provide a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block
(preferred) or a minimum of 20 (25 preferred) freshly cut unstained tumor slides from
the most recently collected, available tumor tissue for oncogene that encodes for
phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutation testing

- A valid cobas PIK3CA mutation result by central testing is required

- Adequate hematologic and end-organ function within 28 days prior to treatment
initiation
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Human epidermal growth factor receptor 2 (HER2)-positive disease by local laboratory
testing (immunohistochemistry 3 positive [IHC 3+] staining or in situ hybridization
positive)

- Prior treatment with fulvestrant

- Prior treatment with a phosphatidylinositol 3-kinase (PI3K) inhibitor, mammalian
target of rapamycin (mTOR) inhibitor (e.g. everolimus), or protein kinase B (AKT)
inhibitor

- Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1

- Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1

- All acute treatment-related toxicity must have resolved to Grade less than or equal to
(</=) 1 or be deemed stable by the Investigator

- Prior treatment with greater than (>) 1 cytotoxic chemotherapy regimen for metastatic
breast cancer

- Concurrent hormone replacement therapy

- Known untreated or active central nervous system (CNS) metastases

- Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications

- History of inflammatory bowel disease or active bowel inflammation

- Clinically significant cardiac or pulmonary dysfunction

- Clinically significant history of liver disease, including cirrhosis, current alcohol
abuse, or current known active infection with human immunodeficiency virus (HIV),
hepatitis B or C virus

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital; Cancer Therapy Centre - Liverpool
Recruitment hospital [2] 0 0
Macquarie University Hospital - Sydney
Recruitment hospital [3] 0 0
Newcastle Mater Misericordiae Hospital; Oncology - Waratah
Recruitment hospital [4] 0 0
Mater Hospital; Oncology - Brisbane
Recruitment hospital [5] 0 0
Austin Hospital; Medical Oncology - Heidelberg
Recruitment hospital [6] 0 0
Sunshine Hospital; Oncology Research - St Albans
Recruitment hospital [7] 0 0
St John of God Murdoch Hospital; Oncology West - Murdoch
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2109 - Sydney
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4101 - Brisbane
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
- St Albans
Recruitment postcode(s) [7] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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United States of America
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Georgia
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Illinois
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United States of America
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Maryland
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United States of America
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Massachusetts
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Missouri
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New Jersey
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New York
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Oregon
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Pennsylvania
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Wien
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Bosnia and Herzegovina
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Banja Luka
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Bosnia and Herzegovina
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Sarajevo
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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China
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Changchun
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Jilin City
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China
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Zhejiang
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Colombia
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Bogota
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Colombia
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Monteria
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Praha 2
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Finland
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Kuopio
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Turku
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Dijon
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La Roche Sur Yon
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Pierre Benite
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Strasbourg
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Vandoeuvre-les-nancy
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Germany
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Bad Nauheim
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Germany
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Berlin
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Essen
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Hamburg
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Trier
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Patras
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Campania
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Liguria
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Italy
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Lombardia
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Italy
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Sicilia
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Italy
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Toscana
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Veneto
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Korea, Republic of
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Busan
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Mexico
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D.f.
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Distrito Federal
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Mexico
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Mexico City
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Mexico
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Monterrey
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Mexico
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Oaxaca
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Netherlands
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Alkmaar
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Netherlands
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Arnhem
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Peru
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Lima
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Peru
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Trujillo
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Poland
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Bialystok
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Bydgoszcz
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Gdansk
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Poland
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Konin
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Poland
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Kraków
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Lodz
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Lublin
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Poland
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Szczecin
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Almada
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Portugal
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Lisboa
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Portugal
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Porto
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Romania
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Bucuresti
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Romania
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Cluj Napoca
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Romania
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Craiova
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Romania
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Iasi
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Arkhangelsk
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Russian Federation
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Ivanovo
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Russian Federation
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Kazan
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Russian Federation
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Orenburg
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Russian Federation
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Saint-Petersburg
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Serbia
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Belgrade
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Spain
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LA Coruña
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Spain
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Madrid
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Spain
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Tenerife
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Spain
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Vizcaya
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Spain
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Barcelona
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Spain
State/province [107] 0 0
Valencia
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Spain
State/province [108] 0 0
Zaragoza
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Sweden
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Linköping
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Sweden
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Stockholm
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Sweden
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Uppsala
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Taiwan
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Taipei City
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Taiwan
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Taipei
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Thailand
State/province [114] 0 0
Bangkok
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Thailand
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Chiang Mai
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Turkey
State/province [116] 0 0
Adana
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Turkey
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Edirne
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Turkey
State/province [118] 0 0
Istanbul
Country [119] 0 0
Turkey
State/province [119] 0 0
Izmir
Country [120] 0 0
Turkey
State/province [120] 0 0
Sihhiye/Ankara

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This international, multicenter, randomized, double-blinded, placebo-controlled study is
designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo +
fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal
growth factor receptor-2 (HER2)-negative, oncogene that encodes for
phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally
advanced or metastatic breast cancer after recurrence or progression during or after an
aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm
versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant
tumors via central testing. The anticipated duration of the study is approximately 3.5 years.
Trial website
https://clinicaltrials.gov/show/NCT02340221
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications