Breast CancerNCT02326857
Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 9 sites in 5 countries.
Trial summary
Background: Researchers want to learn more about breast cancer in Latin American women. They also want to learn how and why women respond differently to standard treatment. Tissue and blood samples from women with breast cancer are needed to study this disease in order to find new ways to prevent, diagnose, and treat… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,334 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 23 Dec 2014to 23 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The primary objective of the study is to characterize the distribution of invasive breast cancer stage II or III by immunohistochemistry and gene expression profiles in Latin American women. The study has two parts: Part A is a descriptive, observational part to characterize the molecular profile of breast cancer in Latin American women; Part B, the standard neoadjuvant chemotherapy treatment part of the study, seeks to identify any associations between response to neoadjuvant therapy and the molecular profiles. Participants will be followed for a period of 5 years to determine any associations between the molecular profiles and disease evolution following standard treatment.
Who may be able to join
- 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.
- 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:
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- 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.
- -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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Mexico3 sites
Instituto Jalisciense de Cancerologia
Guadalajara
Universidad de Guadalajara
Guadalajara
Universidad de Sonora
Sonora
Brazil2 sites
Instituto Nacional de Cancer (INCA)
Rio de Janeiro
Instituto do C(SqrRoot) ncer do Estado de S(SqrRoot) o Paulo
São Paulo
Uruguay2 sites
Institito Nacional de C(SqrRoot)(Degree)ncer
Montevideo
Instituto Pasteur de Montevideo
Montevideo
About this study
Background:
- Researchers want to learn more about breast cancer in Latin American women. They also want to learn how and why women respond differently to standard treatment. Tissue and blood samples from women with breast cancer are needed to study this disease in order to find new ways to prevent, diagnose, and treat it.
Read more
Objective:
- To learn more about the biology and genetics of breast cancer in Latin American women.
Eligibility:
- Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II or III breast cancer. They must still be active and able to self-care.
Design:
- Participants are only agreeing to have extra tissue or blood samples collected. They are also letting tissue left over from surgery be used for research. No procedures outside of standard care will be done.
- Participants may have a medical history, physical exam, and blood tests. They may have a pregnancy test. They may have an ultrasound, mammogram, and other scans. They may have an intravenous needle placed in an arm vein.
- Participants may have a core biopsy. For this, a needle is inserted into the breast. A piece of tissue is extracted.
- Participants who have chemotherapy may have blood taken after treatment/before surgery. Tissue may also be collected.
- Participants will complete a questionnaire. It will ask about their social and economic background. It will ask about their family history of cancer. It will also ask about access to diagnosis and treatment of breast cancer.
- Participants may be followed for up to 5 years.
Read the detailed description
The primary objective of this study is to characterize the distribution of molecular profiles in Latin American women with AJCC 7 clinical stage II or III breast cancer. The molecular profiles will be correlated with epidemiological, histological, and clinical characteristics, including pathologic response to standard neoadjuvant chemotherapy. Moreover, this study intends to define a molecular signature that will predict response to neoadjuvant therapy in breast cancer. This is a prospective cohort study in which no investigational drugs will be administered to participants. The study will be conducted at participating institutions in Argentina, Brazil, Chile, Mexico, and Uruguay.
- Conditions
- Breast Cancer
- Keywords
- Molecular Profiles of Breast Cancer in Latin American Women, AJCC 7 Clinical Stage II to III, Breast Cancer Observational Study, Prospective Cohort, Epidemiological, Histological, and Clinical Data
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women with breast cancer | Observational study of women with Stage II/III locally advanced breast cancer in Latin America |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize distribution of invasive breast cancer stage II and III molecular profiles
This project will provide valuable information on the effectiveness of standard chemotherapy in Latin American women.
Measured: 2 years post accrual closure
Secondary outcomes (6)
Association of molecular profile with tumor histological type, size,lymph node status and surrogate markers
Measured: 2 years post accrual closure
Proportion of participants in each molecular profile who achieve pCR to neoadjuvant chemotherpay
Measured: 2 years post accrual closure
RCB following neoadjuvant chemotherapy
Measured: 2 years post accrual closure
Predictive and prognostic gene expression signatures
Measured: 2 years post accrual closure
Survival-OS, DFS, and TFF
Measured: 2 years post accrual closure
Demographic and epidemiological characteristics of the population by molecular profile
Measured: 2 years post accrual closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study start23 Dec 2014
- Primary completion23 Dec 2014
- Study completion23 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,334 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas G Gross, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326857
- Sponsor's protocol ID
- 999915055
- Other IDs
- 15-C-N055
- Status last verified
- Sep 2020
- First submitted
- 25 Dec 2014
- Last updated
- 25 Sep 2020
- Results posted
- No
Publications
Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.
PubMed 10963602Guarneri V, Broglio K, Kau SW, Cristofanilli M, Buzdar AU, Valero V, Buchholz T, Meric F, Middleton L, Hortobagyi GN, Gonzalez-Angulo AM. Prognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factors. J Clin Oncol. 2006 Mar 1;24(7):1037-44. doi: 10.1200/JCO.2005.02.6914.
PubMed 16505422Vona-Davis L, Rose DP. The influence of socioeconomic disparities on breast cancer tumor biology and prognosis: a review. J Womens Health (Larchmt). 2009 Jun;18(6):883-93. doi: 10.1089/jwh.2008.1127.
PubMed 19514831Llera AS, Abdelhay ESFW, Artagaveytia N, Daneri-Navarro A, Muller B, Velazquez C, Alcoba EB, Alonso I, Alves da Quinta DB, Binato R, Bravo AI, Camejo N, Carraro DM, Castro M, Castro-Cervantes JM, Cataldi S, Cayota A, Cerda M, Colombo A, Crocamo S, Del Toro-Arreola A, Delgadillo-Cisterna R, Delgado L, Dreyer-Breitenbach M, Fejerman L, Fernandez EA, Fernandez J, Fernandez W, Franco-Topete RA, Gabay C, Gaete F, Garibay-Escobar A, Gomez J, Greif G, Gross TG, Guerrero M, Henderson MK, Lopez-Munoz ME, Lopez-Vazquez A, Maldonado S, Moran-Mendoza AJ, Nagai MA, Oceguera-Villanueva A, Ortiz-Martinez MA, Quintero J, Quintero-Ramos A, Reis RM, Retamales J, Rivera-Claisse E, Rocha D, Rodriguez R, Rosales C, Salas-Gonzalez E, Sanchotena V, Segovia L, Sendoya JM, Silva-Garcia AA, Trinchero A, Valenzuela O, Vedham V, Zagame L; United States-Latin American Cancer Research Network (US-LACRN); Podhajcer OL. The Transcriptomic Portrait of Locally Advanced Breast Cancer and Its Prognostic Value in a Multi-Country Cohort of Latin American Patients. Front Oncol. 2022 Mar 22;12:835626. doi: 10.3389/fonc.2022.835626. eCollection 2022.
PubMed 35433488
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Profiling of Stage II and III Breast Cancer in Latin American Women Receiving Standard-of-Care Treatment
- ClinicalTrials.gov ID
- NCT02326857
- Acronym / sponsor ID
- 999915055
- Conditions
- Breast Cancer
- Keywords
- Molecular Profiles of Breast Cancer in Latin American Women, AJCC 7 Clinical Stage II to III, Breast Cancer Observational Study, Prospective Cohort, Epidemiological, Histological, and Clinical Data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,334 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 Dec 2014 (actual)
- Primary completion
- 23 Dec 2014 (actual)
- Study completion
- 23 Sep 2020 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Researchers want to learn more about breast cancer in Latin American women. They also want to learn how and why women respond differently to standard treatment. Tissue and blood samples from women with breast cancer are needed to study this disease in order to find new ways to prevent, diagnose, and treat it.
Objective:
- To learn more about the biology and genetics of breast cancer in Latin American women.
Eligibility:
- Latin American women age 18 and older of all ethnic backgrounds who have clinical stage II or III breast cancer. They must still be active and able to self-care.
Design:
- Participants are only agreeing to have extra tissue or blood samples collected. They are also letting tissue left over from surgery be used for research. No procedures outside of standard care will be done.
- Participants may have a medical history, physical exam, and blood tests. They may have a pregnancy test. They may have an ultrasound, mammogram, and other scans. They may have an intravenous needle placed in an arm vein.
- Participants may have a core biopsy. For this, a needle is inserted into the breast. A piece of tissue is extracted.
- Participants who have chemotherapy may have blood taken after treatment/before surgery. Tissue may also be collected.
- Participants will complete a questionnaire. It will ask about their social and economic background. It will ask about their family history of cancer. It will also ask about access to diagnosis and treatment of breast cancer.
- Participants may be followed for up to 5 years.
Detailed description
The primary objective of this study is to characterize the distribution of molecular profiles in Latin American women with AJCC 7 clinical stage II or III breast cancer. The molecular profiles will be correlated with epidemiological, histological, and clinical characteristics, including pathologic response to standard neoadjuvant chemotherapy. Moreover, this study intends to define a molecular signature that will predict response to neoadjuvant therapy in breast cancer. This is a prospective cohort study in which no investigational drugs will be administered to participants. The study will be conducted at participating institutions in Argentina, Brazil, Chile, Mexico, and Uruguay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with breast cancer | – | –Observational study of women with Stage II/III locally advanced breast cancer in Latin America |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The primary objective of the study is to characterize the distribution of invasive breast cancer stage II or III by immunohistochemistry and gene expression profiles in Latin American women. The study has two parts: Part A is a descriptive, observational part to characterize the molecular profile of breast cancer in Latin American women; Part B, the standard neoadjuvant chemotherapy treatment part of the study, seeks to identify any associations between response to neoadjuvant therapy and the molecular profiles. Participants will be followed for a period of 5 years to determine any associations between the molecular profiles and disease evolution following standard treatment.
Key inclusion criteria (14 listed)
- 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.
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize distribution of invasive breast cancer stage II and III molecular profiles
Time frame: 2 years post accrual closure
This project will provide valuable information on the effectiveness of standard chemotherapy in Latin American women.
6 secondary outcomes
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
Predictive and prognostic gene expression signatures
Time frame: 2 years post accrual closure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Background: PubMed 10963602Perou CM, Sorlie T, Eisen MB, van de Rijn M, Jeffrey SS, Rees CA, Pollack JR, Ross DT, Johnsen H, Akslen LA, Fluge O, Pergamenschikov A, Williams C, Zhu SX, Lonning PE, Borresen-Dale AL, Brown PO, Botstein D. Molecular portraits of human breast tumours. Nature. 2000 Aug 17;406(6797):747-52. doi: 10.1038/35021093.
- Background: PubMed 16505422Guarneri V, Broglio K, Kau SW, Cristofanilli M, Buzdar AU, Valero V, Buchholz T, Meric F, Middleton L, Hortobagyi GN, Gonzalez-Angulo AM. Prognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factors. J Clin Oncol. 2006 Mar 1;24(7):1037-44. doi: 10.1200/JCO.2005.02.6914.
- Background: PubMed 19514831Vona-Davis L, Rose DP. The influence of socioeconomic disparities on breast cancer tumor biology and prognosis: a review. J Womens Health (Larchmt). 2009 Jun;18(6):883-93. doi: 10.1089/jwh.2008.1127.
- Derived from this study: PubMed 35433488Llera AS, Abdelhay ESFW, Artagaveytia N, Daneri-Navarro A, Muller B, Velazquez C, Alcoba EB, Alonso I, Alves da Quinta DB, Binato R, Bravo AI, Camejo N, Carraro DM, Castro M, Castro-Cervantes JM, Cataldi S, Cayota A, Cerda M, Colombo A, Crocamo S, Del Toro-Arreola A, Delgadillo-Cisterna R, Delgado L, Dreyer-Breitenbach M, Fejerman L, Fernandez EA, Fernandez J, Fernandez W, Franco-Topete RA, Gabay C, Gaete F, Garibay-Escobar A, Gomez J, Greif G, Gross TG, Guerrero M, Henderson MK, Lopez-Munoz ME, Lopez-Vazquez A, Maldonado S, Moran-Mendoza AJ, Nagai MA, Oceguera-Villanueva A, Ortiz-Martinez MA, Quintero J, Quintero-Ramos A, Reis RM, Retamales J, Rivera-Claisse E, Rocha D, Rodriguez R, Rosales C, Salas-Gonzalez E, Sanchotena V, Segovia L, Sendoya JM, Silva-Garcia AA, Trinchero A, Valenzuela O, Vedham V, Zagame L; United States-Latin American Cancer Research Network (US-LACRN); Podhajcer OL. The Transcriptomic Portrait of Locally Advanced Breast Cancer and Its Prognostic Value in a Multi-Country Cohort of Latin American Patients. Front Oncol. 2022 Mar 22;12:835626. doi: 10.3389/fonc.2022.835626. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas G Gross, M.D. principal investigator
National Cancer Institute (NCI)
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by National Cancer Institute (NCI) at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Mexico, Brazil, Uruguay, Argentina, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize distribution of invasive breast cancer stage II and III molecular profiles (time frame: 2 years post accrual closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326857, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.