Trial Outcomes & Findings for Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer (NCT NCT03219476)
NCT ID: NCT03219476
Last Updated: 2025-04-29
Results Overview
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+ (up to 25% of cells stained), it's called "HER2 negative." If the score is 2+ (approximately 50% of cells stained), it's called "borderline." A score of 3+ (approximately 75% or more of cells stained) is called "HER2 positive." Upregulation means increased staining from a prior observation; Downregulation means decreased staining from a prior observation; and No Change means similar staining from a prior observation.
COMPLETED
PHASE2
37 participants
At four weeks.
2025-04-29
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Endocrine Therapy Treatment (Physician's Choice)
Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.
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|---|---|
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Overall Study
STARTED
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37
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Overall Study
COMPLETED
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37
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Node-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Endocrine Therapy Treatment (Physician's Choice)
n=37 Participants
Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.
Anastrozole: 1 mg once daily.
Letrozole: 2.5mg once daily.
Exemestane: 25 mg once daily.
Tamoxifen: 20 mg once daily.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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25 Participants
n=39 Participants
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Age, Categorical
>=65 years
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12 Participants
n=39 Participants
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Sex: Female, Male
Female
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37 Participants
n=39 Participants
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Sex: Female, Male
Male
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0 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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36 Participants
n=39 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=39 Participants
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Race (NIH/OMB)
White
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36 Participants
n=39 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=39 Participants
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Region of Enrollment
United States
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37 participants
n=39 Participants
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PRIMARY outcome
Timeframe: At four weeks.Population: All 37 subjects were analyzed for each of the protein markers.
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+ (up to 25% of cells stained), it's called "HER2 negative." If the score is 2+ (approximately 50% of cells stained), it's called "borderline." A score of 3+ (approximately 75% or more of cells stained) is called "HER2 positive." Upregulation means increased staining from a prior observation; Downregulation means decreased staining from a prior observation; and No Change means similar staining from a prior observation.
Outcome measures
| Measure |
Change From Baseline in Human Epidermal Growth Factor Receptor 1 (HER1) Cell Protein Levels.
n=37 Participants
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 1 (HER1) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER1 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER1 positive."
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Change From Baseline in Human Epidermal Growth Factor Receptor 2 (HER2) Cell Protein Levels.
n=37 Participants
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 2 (HER2) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER2 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER2 positive."
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Change From Baseline in Human Epidermal Growth Factor Receptor 3 (HER3) Cell Protein Levels.
n=37 Participants
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 3 (HER3) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER3 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER3 positive."
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Change From Baseline in Human Epidermal Growth Factor Receptor 4 (HER4) Cell Protein Levels.
n=37 Participants
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 4 (HER4) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER4 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER4 positive."
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|---|---|---|---|---|
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Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.
Upregulation
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1 Participants
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17 Participants
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1 Participants
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1 Participants
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Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.
Downregulation
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0 Participants
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2 Participants
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18 Participants
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18 Participants
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Change in Baseline of Cancer Cell Protein Levels of Human Epidermal Growth Factor Receptor (HER) Family Members (HER1-4) Following Neoadjuvant Endocrine Therapy.
No Change
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36 Participants
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18 Participants
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18 Participants
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18 Participants
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SECONDARY outcome
Timeframe: At four weeks.This will be assessed by World Health Organization (WHO) criteria: * Complete Response (CR): The disappearance of all known disease, based on a comparison between the measurements at baseline and after four weeks of treatment with neoadjuvant therapy. * Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size), based on a comparison between the measurements at baseline and after four weeks of treatment with neoadjuvant therapy. * No Change (NC): A 50% decrease in total tumor size cannot be established nor has a 25% increase in the size of the lesion been demonstrated. * Progressive Disease (PD): A 25% or greater increase in the total tumor size of the measurable lesions (calculated on the smallest diameter recorded over time).
Outcome measures
| Measure |
Change From Baseline in Human Epidermal Growth Factor Receptor 1 (HER1) Cell Protein Levels.
n=37 Participants
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 1 (HER1) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER1 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER1 positive."
|
Change From Baseline in Human Epidermal Growth Factor Receptor 2 (HER2) Cell Protein Levels.
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 2 (HER2) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER2 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER2 positive."
|
Change From Baseline in Human Epidermal Growth Factor Receptor 3 (HER3) Cell Protein Levels.
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 3 (HER3) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER3 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER3 positive."
|
Change From Baseline in Human Epidermal Growth Factor Receptor 4 (HER4) Cell Protein Levels.
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 4 (HER4) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER4 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER4 positive."
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|---|---|---|---|---|
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Number of Subjects Who Achieve Complete Radiographic Response.
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0 Participants
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—
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—
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—
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SECONDARY outcome
Timeframe: At four weeks.This will be assessed by World Health Organization (WHO) criteria: * Complete Response (CR): The disappearance of all known disease, based on a comparison between the measurements at baseline and after four weeks of treatment with neoadjuvant therapy. * Partial Response (PR): A 50% or greater decrease in the product of the bi-dimensional measurements of the lesion (total tumor size), based on a comparison between the measurements at baseline and after four weeks of treatment with neoadjuvant therapy. * No Change (NC): A 50% decrease in total tumor size cannot be established nor has a 25% increase in the size of the lesion been demonstrated. * Progressive Disease (PD): A 25% or greater increase in the total tumor size of the measurable lesions (calculated on the smallest diameter recorded over time).
Outcome measures
| Measure |
Change From Baseline in Human Epidermal Growth Factor Receptor 1 (HER1) Cell Protein Levels.
n=37 Participants
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 1 (HER1) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER1 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER1 positive."
|
Change From Baseline in Human Epidermal Growth Factor Receptor 2 (HER2) Cell Protein Levels.
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 2 (HER2) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER2 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER2 positive."
|
Change From Baseline in Human Epidermal Growth Factor Receptor 3 (HER3) Cell Protein Levels.
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 3 (HER3) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER3 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER3 positive."
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Change From Baseline in Human Epidermal Growth Factor Receptor 4 (HER4) Cell Protein Levels.
ImmunoHistoChemistry (IHC) will be used. The IHC test gives a score of 0 to 3+ that measures the amount of Human Epidermal Growth Factor Receptor 4 (HER4) receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER4 negative." If the score is 2+, it's called "borderline." A score of 3+ is called "HER4 positive."
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|---|---|---|---|---|
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Number of Subjects Who Achieve a Partial Radiographic Response.
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1 Participants
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—
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—
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—
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Adverse Events
Neoadjuvant Endocrine Therapy Treatment (Physician's Choice)
Serious adverse events
| Measure |
Neoadjuvant Endocrine Therapy Treatment (Physician's Choice)
n=37 participants at risk
Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.
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|---|---|
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Infections and infestations
Infection
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2.7%
1/37 • Number of events 1 • Four weeks.
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Other adverse events
| Measure |
Neoadjuvant Endocrine Therapy Treatment (Physician's Choice)
n=37 participants at risk
Once enrolled, patients would be treated with the current standard-of-care endocrine therapy. Choice of endocrine therapy (aromatase inhibitors or tamoxifen) would be decided by medical oncologist, following a review of the patient's medical history and menstrual status. The patient would be treated with endocrine therapy in a neoadjuvant setting for four weeks, with dosing continuing until surgery.
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|---|---|
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Musculoskeletal and connective tissue disorders
Arthralgia
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5.4%
2/37 • Number of events 2 • Four weeks.
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Vascular disorders
Hypertension
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5.4%
2/37 • Number of events 2 • Four weeks.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place