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← FASLODEX: metastatic Breast cancer with HR positive, HER2 negative after prior therapy

NCT01272037 · STUDY IN CONTEXT

Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer

Draft scope assessment: unclear. Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section.

For the participants flow and baseline characteristics summary, 5018 eligible participants were included. However, among them, there were 34 participants (10 in the chemo and endocrine arm, and 24 in the endocrine alone arm) that withdrew consent immediately after randomization; thus these participants were excluded from the survival analyses.

→

secondary · POSTED

Only adverse events that are possibly, probably, or definitely related to study drug are reported. Assessed at 6, 12, 24, and 36 months after randomization.

Eligible participants who received at least one dose of protocol treatment and assessed for Adverse Event.

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secondary · NOT_POSTED

Time from date of randomization (2nd Registration) to date of death due to any cause. Participants last known to be alive are censored at their last contact date.

Source null

→

secondary · NOT_POSTED

Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Participants last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. This secondary outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence.

Source null

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secondary · NOT_POSTED

Time from date of randomization (2nd Registration) to date of invasive local or regional recurrence. Participants last known to be alive without recurrence are censored at their last contact date. Participants with distant recurrence, second primary cancer or death are censored at the time of that event. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence.

Source null

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secondary · NOT_POSTED

Anxiety is evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form. Raw PROMIS scores can be re-scaled into T-scores based on a reference population with a mean score of 50 and a standard deviation of 10. Higher scores reflect greater anxiety. PROMIS Anxiety scores at the 6 month timepoint will be compared between the two randomized study arms separately by menopausal status.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

PROMIS · Participant-Reported Anxiety

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01272037
qol key
qol-0005
source section id
NCT01272037-om-0005
source outcome index
5
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Participant-Reported Anxiety
measure definition
Anxiety is evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form. Raw PROMIS scores can be re-scaled into T-scores based on a reference population with a mean score of 50 and a standard deviation of 10. Higher scores reflect greater anxiety. PROMIS Anxiety scores at the 6 month timepoint will be compared between the two randomized study arms separately by menopausal status.
time frame
6 months after randomization
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EQ-5D · Participant-Reported Health Status

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01272037
qol key
qol-0006
source section id
NCT01272037-om-0006
source outcome index
6
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Participant-Reported Health Status
measure definition
Assessed using the EuroQol-5D (EQ-5D), in which participants rate their health status in five different health-related domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The raw scores can be converted to index scores on a scale of 0 to 1, where a higher index score represents better health. EQ-5D index scores at the 6-month timepoint will be compared between the two randomized study arms separately by menopausal status.
time frame
6 months after randomization
analysis role
secondary
reporting status
NOT_POSTED
higher is better
1
direction quote
higher index score represents better
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-breast-cancer-faslodex-f8107dd2
nct id
NCT01272037
trial label
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
applicability
unclear
applicability note
Attached because the study's own record names HER2. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0000
    source section id
    NCT01272037-om-0000
    source outcome index
    0
    endpoint
    Invasive Disease-Free Survival (IDFS)
    endpoint definition
    From date of randomization (2nd Registration) to date of first invasive recurrence (local, regional or distant), second invasive primary cancer (breast or not), or death due to any cause. Patients last known to be alive who have not experienced recurrence or second primary cancer are censored at their last contact date. This is the STEEP definition of invasive disease-free survival. Kaplan-Meier estimates were calculated for the 5-year IDFS rate. Due to the results of the third prespecified interim analysis, prespecified separate analyses were conducted for all outcomes by menopausal status (see Statistical Analysis 2). The NCI and data and safety monitoring committee recommended early reporting of the data. After the primary analysis, changes in eligibility status were identified for three participants, making the population of eligible and evaluable participants different between the reporting of this outcome and both the Participant Flow section and the Adverse Events section.
    time origin
    5 years after randomization
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    For the participants flow and baseline characteristics summary, 5018 eligible participants were included. However, among them, there were 34 participants (10 in the chemo and endocrine arm, and 24 in the endocrine alone arm) that withdrew consent immediately after randomization; thus these participants were excluded from the survival analyses.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0001
    source section id
    NCT01272037-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
    endpoint definition
    Only adverse events that are possibly, probably, or definitely related to study drug are reported. Assessed at 6, 12, 24, and 36 months after randomization.
    time origin
    Duration of treatment and follow-up until death or 3 years after randomization
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants who received at least one dose of protocol treatment and assessed for Adverse Event.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0002
    source section id
    NCT01272037-om-0002
    source outcome index
    2
    endpoint
    Overall Survival (OS)
    endpoint definition
    Time from date of randomization (2nd Registration) to date of death due to any cause. Participants last known to be alive are censored at their last contact date.
    time origin
    5.5 years after randomization
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0003
    source section id
    NCT01272037-om-0003
    source outcome index
    3
    endpoint
    Distant Disease-Free Survival (DDFS)
    endpoint definition
    Time from date of randomization (2nd Registration) to date of invasive distant disease recurrence, second invasive primary cancer (breast or not) or death due to any cause. Participants last known to be alive who have not experienced distant recurrence, or second primary cancer are censored at their last contact date. This secondary outcome requires continuing to follow the patient after local recurrence in order to ascertain subsequent distant recurrence. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence.
    time origin
    5.5 years after randomization
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0004
    source section id
    NCT01272037-om-0004
    source outcome index
    4
    endpoint
    Local Disease-Free Interval (LDFI)
    endpoint definition
    Time from date of randomization (2nd Registration) to date of invasive local or regional recurrence. Participants last known to be alive without recurrence are censored at their last contact date. Participants with distant recurrence, second primary cancer or death are censored at the time of that event. Invasive recurrence is defined as: appearance of any new invasive lesion(s) during or after protocol treatment. Whenever possible, recurrences should be documented histologically. Invasive recurrence includes local, regional, or distant recurrence with an invasive component. A new diagnosis of ipsilateral or contralateral DCIS without an invasive component is not considered to be a recurrence.
    time origin
    From date of randomization to a maximum of 5.5 years or death
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0005
    source section id
    NCT01272037-om-0005
    source outcome index
    5
    endpoint
    Participant-Reported Anxiety
    endpoint definition
    Anxiety is evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form. Raw PROMIS scores can be re-scaled into T-scores based on a reference population with a mean score of 50 and a standard deviation of 10. Higher scores reflect greater anxiety. PROMIS Anxiety scores at the 6 month timepoint will be compared between the two randomized study arms separately by menopausal status.
    time origin
    6 months after randomization
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Chemo and Endocrine Therapy
    regimen
    Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    2487
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01272037-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Endocrine Therapy Alone
    regimen
    Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    2497
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01272037-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Chemo and Endocrine Therapy
    regimen
    Participants receive a protocol-approved chemotherapy regimen based on the participant and/or physician preference. Participants then receive a protocol-approved adjuvant endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    2062
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01272037-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Endocrine Therapy Alone
    regimen
    Participants receive a protocol-approved endocrine therapy for 5-10 years in the absence of disease progression or unacceptable toxicity.
    analyzed count
    2342
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01272037-om-0001#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    harm key
    EG000
    source section id
    NCT01272037-ae
    event group key
    EG000
    event group label
    Chemo and Endocrine Therapy
    serious affected
    14
    serious at risk
    2062
    other affected
    151
    other at risk
    2062
    frequency threshold
    5
    collection period
    Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
    event definition
    Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    harm key
    EG001
    source section id
    NCT01272037-ae
    event group key
    EG001
    event group label
    Endocrine Therapy Alone
    serious affected
    9
    serious at risk
    2342
    other affected
    2
    other at risk
    2342
    frequency threshold
    5
    collection period
    Adverse Events were assessed for the duration of treatment and follow-up until death or 3 years after randomization. All-Cause Mortality was assessed up to 5 years from randomization. CTCAE Version 4.0 was used for routine toxicity reporting. Version 5.0 was used for Serious Adverse Event (SAE) reporting.
    event definition
    Only participants who received protocol treatment and assessed for adverse event were included in the adverse event result: 2062 in the Chemo and Endocrine Therapy arm and 2342 in the Endocrine Therapy Alone arm. All-Cause mortality is reported for all eligible and evaluable participants (2487 in the Chemo and Endocrine arm and 2497 in the endocrine therapy arm). Due to eligibility changes found after the primary analysis, the number at risk differs from the Outcomes Section.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    qol key
    qol-0005
    source section id
    NCT01272037-om-0005
    source outcome index
    5
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Participant-Reported Anxiety
    measure definition
    Anxiety is evaluated with the Patient-Reported Outcomes Measurement Information System (PROMIS) Emotional Distress-Anxiety Short Form. Raw PROMIS scores can be re-scaled into T-scores based on a reference population with a mean score of 50 and a standard deviation of 10. Higher scores reflect greater anxiety. PROMIS Anxiety scores at the 6 month timepoint will be compared between the two randomized study arms separately by menopausal status.
    time frame
    6 months after randomization
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-breast-cancer-faslodex-f8107dd2
    nct id
    NCT01272037
    qol key
    qol-0006
    source section id
    NCT01272037-om-0006
    source outcome index
    6
    instrument
    EQ-5D
    instrument basis
    matched 'eq-5d' in the study's own wording
    scale title
    Participant-Reported Health Status
    measure definition
    Assessed using the EuroQol-5D (EQ-5D), in which participants rate their health status in five different health-related domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The raw scores can be converted to index scores on a scale of 0 to 1, where a higher index score represents better health. EQ-5D index scores at the 6-month timepoint will be compared between the two randomized study arms separately by menopausal status.
    time frame
    6 months after randomization
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    1
    direction quote
    higher index score represents better
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice