Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02326857
• Date of registration: 25/12/2014
• Prospective Registration: No
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment
• Scientific title: Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment
• Date of first enrolment: December 23, 2014
• Target sample size: 1334
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02326857
• Study type: Observational

Countries of recruitment

Argentina, Brazil, Chile, Mexico, Uruguay

Contacts

• Name: Thomas G Gross, M.D.
• Affiliation: National Cancer Institute (NCI)

Key inclusion & exclusion criteria

- ELIGIBILITY CRITERIA:

ELIGIBILITY CRITERIA FOR PART A OF THE STUDY:

INCLUSION CRITERIA:

- Women age greater than or equal to 18 years.

- AJCC 7 clinical stage II or III breast cancer. Clarification: Participants with
clinical stage II breast cancer who are later classified as histologically-confirmed
stage I will remain on study; participants who are later classified as
histologically-confirmed stage IV breast cancer will be taken off study.

- Biopsy-accessible breast tumor or participant candidates for primary surgery.

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

EXCLUSION CRITERIA:

- Prior history of non-breast malignancy (excluding in situ cancers treated only by
local excision and basal cell and squamous cell carcinomas of the skin) within 5 years
prior to enrollment in this study.

- Bilateral invasive or in-situ breast cancer.

- Inflammatory breast cancer.

- Clinical or radiological evidence of distant metastases by computed tomography (CT),
chest X-ray, abdominal/thoracic ultrasound, bone scan, and/or liver function tests
including total bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase
(AST) and alkaline phosphatase (ALP), within ranges defined in eligibility criteria
for Part B of the study.

- Prior hormone therapy, chemotherapy, biologic, targeted therapies, or radiation
therapy for this malignancy. Prior bisphosphonate therapy is allowed.

- Pregnant and lactating women: Effects on a developing human fetus of chemotherapeutic
agents at the recommended therapeutic dose remain incompletely defined. For this
reason and because these agents may be teratogenic, women of child-bearing potential
must agree to use adequate contraception (double barrier methods of birth control or
abstinence) prior to study entry and for the duration of study treatment phase. Should
a woman become pregnant or suspect she is pregnant while participating in this study,
she should inform her study physician immediately.

- Because there is an unknown but potential risk for adverse events in nursing infants
secondary to treatment of the mother with chemotherapeutic agents, women who are
breastfeeding will be excluded. If a participant is of child-bearing potential (women
are not considered of childbearing potential if they are at least 2 years
postmenopausal and/or surgically sterile), she must have documented negative serum or
negative urine pregnancy tests within 14 days of entry to the study (i.e., within 14
days of signing the informed consent document).

- Subjects with psychiatric illness and/or other specific situations that would limit
compliance with study requirements and compromise participant follow-up.

- Lack of ability to understand and willingness to sign a written informed consent
document.

Note: Subjects who were enrolled prior to this amendment will be considered eligible even
if the HIV/Hep C and pregnancy test were not preformed due to each country standards.

ELIGIBILITY CRITERIA FOR PART B OF THE STUDY:

Participants, who successfully enrolled into the first part of the study and who, according
to local institutional guidelines, are candidates for neoadjuvant chemotherapy will
participate in Part B of the study. Participants must also meet the inclusion and exclusion
criteria described below.

INCLUSION CRITERIA:

- Histologically confirmed new primary adenocarcinoma of the breast AJCC 7 clinical
stage II or III. All histological types are included Hormone status: Any tumor ER/PgR
status, any HER2/neu status as measured by local hospital pathology laboratory
following US LA CRN standard operating procedures (SOPs).

- Normal organ and marrow function as defined below:

- Absolute neutrophil count greater than or equal to 1500/microL

- Platelets greater than or equal to 100,000/microL

- Total bilirubin within normal institutional limits, unless participant has
Gilbert s disease, for which bilirubin must be less than or equal to 2.0 times
upper limits of normal (ULN)

- AST serum glutamic-oxaloacetic transaminase (SGOT)/ALT serum glutamic-pyruvic
transaminase (SGPT) less than or equal to 1.5 times institutional ULN

- ALP less than or equal to 2.5 times institutional ULN

- Creatinine less than or equal to 1.5 times institutional ULN

- Negative serum or urine beta-human chorionic gonadotropin (HCG), unless
participant is post-hysterectomy or menopausal.

EXCLUSION CRITERIA:

- Uncontrolled or severe cardiac disease. Baseline left ventricular ejection fraction
(LVEF) by nuclear imaging or echocardiography must be within normal institutional
limits.

- Use of any investigational agents within 30 days of starting standard chemotherapy
treatment.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to chemotherapeutic agents or accompanying supportive medications.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness and/or other specific situations that would limit
compliance with study requirements and compromise participant follow-up.

INCLUSION OF WOMEN AND MINORITIES:

-Latin American women with breast cancer of all ethnic backgrounds will be included in this
study as participants. There are no expected racial/ethnic differences in the recruitment
effort.



Age minimum: 18 Years
Age maximum: 100 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Primary Outcome(s)

Characterize distribution of invasive breast cancer stage II and III molecular profiles [Time Frame: 2 years post accrual closure]

Secondary Outcome(s)

Survival-OS, DFS, and TFF [Time Frame: 2 years post accrual closure]

Demographic and epidemiological characteristics of the population by molecular profile [Time Frame: 2 years post accrual closure]

Predictive and prognostic gene expression signatures [Time Frame: 2 years post accrual closure]

Association of molecular profile with tumor histological type, size,lymph node status and surrogate markers [Time Frame: 2 years post accrual closure]

Proportion of participants in each molecular profile who achieve pCR to neoadjuvant chemotherpay [Time Frame: 2 years post accrual closure]

RCB following neoadjuvant chemotherapy [Time Frame: 2 years post accrual closure]

Secondary ID(s)

15-C-N055

999915055

Source(s) of Monetary Support

Please refer to primary and secondary sponsors