Adjuvant Therapy, Breast Cancer, HER2-positive Breast Cancer
Conditions
Keywords
HER2-positive Breast Cancer, Adjuvant therapy
Brief summary
The purpose of this study is to describe the demographic and clinical profiles of patients with early-stage HER2+ breast cancer treated with neratinib as an extended adjuvant therapy as part of the Early Access Program (EAP) in Europe.
Detailed description
Eligible patients were selected among those who had received at least one dose of neratinib in the context of the early access program conducted in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP. Patients were followed up until the end of the study observation period/study entry date (05 July 2022). As this study was retrospective, the decision to prescribe neratinib was taken prior to and independent of the proposal to select a patient for this study.
Interventions
None listed
Sponsors
Iqvia Pty Ltd
Pierre Fabre Medicament
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will be eligible for inclusion if they fulfill all of the following criteria: * Age ≥ 18 years at neratinib treatment initiation * Having received at least one initial dose of neratinib as an extended adjuvant therapy for the treatment of early-stage HER2+ breast cancer, in the context of the EAP in Europe, and between August 01, 2017 and December 31, 2020 * Patients (or next of kin/legal representative, if applicable) who provide written informed consent or non-opposition.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Tumor Location | At initial diagnosis | Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer |
| Primary Tumor Histology | At initial diagnosis | Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other |
| Description of Age | At baseline | Age will be assessed in years = neratinib initiation date - date of birth |
| Description of Gender | At baseline | Gender will be described in percentage of Male and Female among patients |
| Description of BMI | At baseline | BMI will be assessed in kg/m2 |
| Menopausal Status | At baseline | Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea |
| Comorbidities | At baseline | Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity. Comorbidities were including but were not limited to: renal disease, liver disease, gastro-intestinal disorders, cardiovascular conditions, skin and subcutaneous disorders, diabetes (type I or II) |
| HER2 Overexpression/Amplification Testing | At initial diagnosis | HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH) |
| Hormone Receptor Status | At initial diagnosis | Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative |
| Histological Grade | At initial diagnosis | Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated |
| Pathologic Stage (AJCC Classification) of Breast Cancer | At initial diagnosis | Higher is the stage worse is the cancer. Stage is defined as: 1A: tumor (T) up to 2 cm + not spread outside the breast; no lymph nodes (LN).1B: Small clusters of cancer cells (CC) (0.2-2 mm) are found in LN, or T in the breast is \< 2 cm and small clusters of CC are found in LN. 2A: No T in the breast, but cancer is in 1-3 axillary LN or in LN near the breastbone or T is 2 cm or smaller + has spread to 1-3 axillary LN or LN near the breastbone, or T is \> 2 cm and \< 5 cm and not spread to LN.2B: T is \> 2 cm and \< 5 cm and has spread to 1-3 axillary LN or LN near the breastbone, or T is \> 5 cm and not spread to the LN. 3A: no T in the breast or the T is any size; cancer is found in 4-9 axillary LN or LN near the breastbone, or T is larger than 5 cm and small clusters of CC found in LN. 3B: T has spread to chest wall or breast skin + may have spread to up to 9 axillary LN. 3C: Cancer has spread to ≥10 axillary LN, LN near the collarbone, or LN near breastbone |
Countries
Belgium, Croatia, France, Italy, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Neratinib Arm Eligible patients were selected among those who had received at least one dose of neratinib in the context of the EAP in Europe between 01 August 2017 and 31 December 2020 (the patient identification period) and residing in one of the five target following countries: Belgium, Croatia, France, Italy and Spain, which were part of the EAP. | 111 |
| Total | 111 |
Baseline characteristics
| Characteristic | Neratinib Arm |
|---|---|
| Age, Continuous | 49.2 years STANDARD_DEVIATION 8.83 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Belgium | 16 participants |
| Region of Enrollment Croatia | 35 participants |
| Region of Enrollment France | 15 participants |
| Region of Enrollment Italy | 21 participants |
| Region of Enrollment Spain | 24 participants |
| Sex: Female, Male Female | 107 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 108 |
| other Total, other adverse events | 10 / 108 |
| serious Total, serious adverse events | 12 / 108 |
Outcome results
Primary
Comorbidities
Comorbidities will be described in number and percentage of patients with at least one relevant comorbidity. Comorbidities were including but were not limited to: renal disease, liver disease, gastro-intestinal disorders, cardiovascular conditions, skin and subcutaneous disorders, diabetes (type I or II)
Time frame: At baseline
Population: FAS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Neratinib Arm | Comorbidities | 26 Participants |
Primary
Description of Age
Age will be assessed in years = neratinib initiation date - date of birth
Time frame: At baseline
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neratinib Arm | Description of Age | 49.2 years | Standard Deviation 8.83 |
Primary
Description of BMI
BMI will be assessed in kg/m2
Time frame: At baseline
Population: FAS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Neratinib Arm | Description of BMI | 26.7 Kg/m² | Standard Deviation 5.36 |
Primary
Description of Gender
Gender will be described in percentage of Male and Female among patients
Time frame: At baseline
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neratinib Arm | Description of Gender | Female | 107 Participants |
| Neratinib Arm | Description of Gender | male | 1 Participants |
Primary
HER2 Overexpression/Amplification Testing
HER2 overexpression/amplification testing will be assessed by Immunohistochemistry (IHC), Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)
Time frame: At initial diagnosis
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neratinib Arm | HER2 Overexpression/Amplification Testing | IHC 3+ (positive) | 81 Participants |
| Neratinib Arm | HER2 Overexpression/Amplification Testing | IHC 2+ (equivocal) | 24 Participants |
| Neratinib Arm | HER2 Overexpression/Amplification Testing | IHC no | 1 Participants |
| Neratinib Arm | HER2 Overexpression/Amplification Testing | Unknown | 2 Participants |
Primary
Histological Grade
Histological grade will be described in percentage of patients with G1 Well differentiated, G2 Moderately differentiated, G3 Poorly differentiated, G4 Undifferentiated
Time frame: At initial diagnosis
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neratinib Arm | Histological Grade | Unavailable | 15 Participants |
| Neratinib Arm | Histological Grade | G1 Well differentiated | 5 Participants |
| Neratinib Arm | Histological Grade | G2 Moderately differentiated | 34 Participants |
| Neratinib Arm | Histological Grade | G3 Poorly differentiated | 54 Participants |
Primary
Hormone Receptor Status
Hormone receptor status will be described in percentage of patients with Estrogen receptor (ER) positive, Progesterone receptor (PR) positive, ER and PR negative
Time frame: At initial diagnosis
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neratinib Arm | Hormone Receptor Status | Estrogen receptor (ER) positive | 91 Participants |
| Neratinib Arm | Hormone Receptor Status | ER negative | 17 Participants |
| Neratinib Arm | Hormone Receptor Status | progesterone receptor (PR) positive | 74 Participants |
| Neratinib Arm | Hormone Receptor Status | PR negative | 34 Participants |
Primary
Menopausal Status
Menopausal status will be described in percentage of Premenopausal, Perimenopausal, Postmenopausal, Surgical/other reason for amenorrhea
Time frame: At baseline
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Neratinib Arm | Menopausal Status | premenopausal | 40 participants |
| Neratinib Arm | Menopausal Status | perimenopausal | 5 participants |
| Neratinib Arm | Menopausal Status | postmenopausal | 34 participants |
| Neratinib Arm | Menopausal Status | surgical/other reason for amenorrhea | 11 participants |
| Neratinib Arm | Menopausal Status | unavailable | 17 participants |
| Neratinib Arm | Menopausal Status | Not applicable (Male) | 1 participants |
Primary
Pathologic Stage (AJCC Classification) of Breast Cancer
Higher is the stage worse is the cancer. Stage is defined as: 1A: tumor (T) up to 2 cm + not spread outside the breast; no lymph nodes (LN).1B: Small clusters of cancer cells (CC) (0.2-2 mm) are found in LN, or T in the breast is \< 2 cm and small clusters of CC are found in LN. 2A: No T in the breast, but cancer is in 1-3 axillary LN or in LN near the breastbone or T is 2 cm or smaller + has spread to 1-3 axillary LN or LN near the breastbone, or T is \> 2 cm and \< 5 cm and not spread to LN.2B: T is \> 2 cm and \< 5 cm and has spread to 1-3 axillary LN or LN near the breastbone, or T is \> 5 cm and not spread to the LN. 3A: no T in the breast or the T is any size; cancer is found in 4-9 axillary LN or LN near the breastbone, or T is larger than 5 cm and small clusters of CC found in LN. 3B: T has spread to chest wall or breast skin + may have spread to up to 9 axillary LN. 3C: Cancer has spread to ≥10 axillary LN, LN near the collarbone, or LN near breastbone
Time frame: At initial diagnosis
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neratinib Arm | Pathologic Stage (AJCC Classification) of Breast Cancer | IIB | 29 Participants |
| Neratinib Arm | Pathologic Stage (AJCC Classification) of Breast Cancer | IIIA | 25 Participants |
| Neratinib Arm | Pathologic Stage (AJCC Classification) of Breast Cancer | I | 21 Participants |
| Neratinib Arm | Pathologic Stage (AJCC Classification) of Breast Cancer | IIA | 17 Participants |
| Neratinib Arm | Pathologic Stage (AJCC Classification) of Breast Cancer | IIIB | 5 Participants |
| Neratinib Arm | Pathologic Stage (AJCC Classification) of Breast Cancer | IIIC | 6 Participants |
| Neratinib Arm | Pathologic Stage (AJCC Classification) of Breast Cancer | Missing | 5 Participants |
Primary
Primary Tumor Histology
Primary tumor histology will be described in percentage of patients with Infiltrating ductal carcinoma, Infiltrating lobular carcinoma, Invasive carcinoma, Tubular, Other
Time frame: At initial diagnosis
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neratinib Arm | Primary Tumor Histology | Infiltrating ductal carcinoma | 56 Participants |
| Neratinib Arm | Primary Tumor Histology | Infiltrating lobular carcinoma | 3 Participants |
| Neratinib Arm | Primary Tumor Histology | Invasive carcinoma | 43 Participants |
| Neratinib Arm | Primary Tumor Histology | Other | 6 Participants |
Primary
Primary Tumor Location
Primary tumor location will be described in percentage of patients with Left Breast cancer, Right Breast cancer
Time frame: At initial diagnosis
Population: FAS
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Neratinib Arm | Primary Tumor Location | Left breast | 47 Participants |
| Neratinib Arm | Primary Tumor Location | Right breast | 62 Participants |