Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Hormones

Exemestane

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Aromasin

Pfizer CT.gov Call Center

The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.

This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.

A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).

An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.

Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.

Age, Continuous

Sex: Female, Male

Ductal Carcinoma

Lobular Carcinoma

Invasive Ductal Carcinoma

Invasive Lobular Carcinoma

Papillary Carcinoma

Medullary Carcinoma

Mucinous (Colloid) Carcinoma

Other

Missing/No Response

Number of participants with different types of tumor such as; ductal carcinoma, lobular carcinoma, invasive ductal carcinoma, invasive lobular carcinoma, papillary carcinoma, medullary carcinoma, mucinous (colloid) carcinoma and others.

Number of Participants With Type of Tumor

Appendicectomy

Breast lump removal

Cataract operation

Cholecystectomy

Hysterectomy

Intervertebral disc operation

Malignant tumor excision

Salpingo-oophorectomy bilateral

Splenectomy

Number of participants who had undergone different type of surgeries which included appendicectomy, breast lump removal, cataract operation, cholecystectomy, hysterectomy, intervertebral disc operation, malignant tumor excision, salpingo-oophorectomy bilateral, and splenectomy.

Number of Participants With Type of Surgery

Participants whose tumor was estrogen receptor positive are reported.

Number of Participants With Estrogen Receptor Positive

Number of Participants With Lymph Node Involvement

Stage I

Stage IIA

Stage IIB

Stage IIIA

Stage IIIB

Stage IIIC

TNM was based on size of tumor, if cancer cells had spread to nearby lymph nodes (LN), or distant (to other parts of the body) metastasis had occurred. Stages included: stage 0(no evidence of cancer cells), stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0), stage IIIC(any TN3M0), stage IV(anyT anyNM1), where T0=early form of tumor, T1= \<2 centimeter(cm), T2=2-5 cm, T3= \>2 cm, T4=large sized tumor, N0=not spread to LN, N1=spread to 1 to 3, N2=spread to 4 to 9, N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Number of Participants With Tumor Node Metastasis (TNM) Stage

Grade 1

Grade 2

Grade 3

Unknown

The grade of a cancer depends on what the cells look like and the growth-rate. Lower grade indicates a slower-growing cancer and a higher grade indicates a faster-growing one. Grade 1 (resemble normal cells, not growing rapidly), Grade 2 (grow faster than normal cells), Grade 3 and 4 (abnormal cells, grow and spread aggressively).

Number of Participants With Histopathological Grade

Number of Participants With Prior Chemotherapy

A total 271 participants were evaluable for this measure.

Number of Participants With Prior Radiation Therapy

The study was prematurely terminated on 31 August 2012 due to unexpected high rate of participant withdrawal caused by Aromasin reimbursement policy change in Romania. There were no safety issues related to study termination.

Pfizer ClinicalTrials.gov Call Center

Grade 4

Grade 5

Missing or Unknown

Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.

Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity

AEs (All Causalities)

SAEs (All Causalities)

AEs (Treatment Related)

SAEs (Treatment Related)

Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug

Week 25 (n=18)

Week 49 (n=8)

Week 73 (n=5)

Week 97 (n=4)

Week 121 (n=4)

Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported.

Number of Missed Exemestane Doses

Adverse event

Insufficient clinical response

Did not meet entrance criteria

Lost to follow-up

No longer willing to participate in study

Other unspecified

Protocol violation

Study terminated by sponsor

Withdrawn due to pregnancy

Number of Participants With Reasons for Discontinuing Exemestane Therapy

Received hormonal therapy

Received chemotherapy

Received both hormonal and chemotherapy

No hormonal or chemotherapy received

Missing or no response

FAS included all participants who had received at least 1 dose of exemestane during the observation period.

Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy

Percentage of Participants Who Discontinued the Exemestane Therapy

A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.

Recurrence-free Survival (RFS)

Time to disease progression was considered complementary to RFS and hence, was not analyzed.

Time to Disease Progression (TTP)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer	NCT01121549	Invasive Early ...	Aromasin	-	Pfizer
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer	NCT01121549	Invasive Early ...	Aromasin	-	Pfizer

Spots Global Cancer Trial Database for invasive early breast cancer