Breast CancerLABCNCT00820690

Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

An observational study of Breast Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The purpose of this study is to analyze gene expression signature and immunohistochemical markers associated with clinical and pathological response to neoadjuvant chemotherapy in locally advanced breast cancer. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: doxorubicin, cyclophosphamide and paclitaxel
Type of treatment: Surgery or procedure
How many people: 80 participants
Where: 1 siteBrazil
Study dates: Jul 2008to Sep 2017
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 70 years
Women only
No healthy volunteers
Adult, Older adult

Study population: women breast cancer, clinical stage III; condition to chemotherapy with doxorubicin/cyclophosphamide and paclitaxel

Who may be able to join

Women with locally advanced women breast cancer
Histology: ductal ou lobular invasive histology
Agreement to take part in the study and signature of the informed consent
Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel
ECOG 0 or I

Who cannot join

Not clinical stage III
Inflammatory breast cancer
Previous treatment
Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma)
Pregnancy
Absence of clinical condition to receive chemotherapy

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Barretos Cancer Hospital
Barretos, São Paulo, 14.784-400

Other trials in Brazil

About this study

Official title: Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer

Read the detailed description

Locally advanced breast cancer is a common condition in development countries. Neoadjuvant chemotherapy gives the opportunity to identify genetic signatures associated with objective clinical and pathological complete responses.

Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.

Conditions: Breast Cancer
Being tested: doxorubicin, cyclophosphamide, paclitaxel, Surgery
Keywords: neoadjuvant chemotherapy, advanced breast cancer, microarray, correlation analysis, oncoplastic surgery
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

doxorubicinDrug
Also called clinical and radiologic response
4 cycles AC: doxorubicin 60mg/m2
cyclophosphamideDrug
Also called clinical and radiologic response
4 cycles AC: cyclophosphamide 600mg/m2
paclitaxelDrug
Also called clinical, radiologic and pathologic response
4 cycles T: paclitaxel 175mg/m2 after 4 AC
SurgeryProcedure or surgery
Also called Oncoplastic surgery, Mastectomy
The surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported.
The oncoplastic surgery rate will be reported

Study groups in NCT00820690
Study group	Role	What they receive
Clinical stage III		Women with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection) Receives: Drug: doxorubicin; Drug: cyclophosphamide; Drug: paclitaxel; Procedure: Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical objective and pathological responses to chemotherapy
Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery.
Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery.
Measured: 8 months

Secondary outcomes (4)

Clinical, radiologic and pathologic correlation
tumor concordance measurement among pre-operative physical examination (PE), mammography (MG), ultrasound (US), breast MRI and post-operative pathologic measurement concordance with PE, MG, US and MRI
Measured: 3 years
Surgery
The use and security of oncoplastic surgery after neoadjuvant chemotherapy
Measured: 5 years
Overall actuarial survival
Measured: 5 years
Pathologic complete response
Pathologic complete response after neoadjuvant chemotherapy
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Sep 2017

First posted12 Jan 2009 (estimated)
Study startJul 2008
Primary completionApr 2012
Study completionSep 2017 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
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: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00820690
Sponsor's protocol ID: 135/2008
Acronym: LABC
Status last verified: Aug 2015
First submitted: 9 Jan 2009
Last updated: 5 Aug 2015
Results posted: No
Data monitoring committee: No

Publications

Folgueira MA, Carraro DM, Brentani H, Patrao DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vencio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Goes JC, Brentani MM. Gene expression profile associated with response to doxorubicin-based therapy in breast cancer. Clin Cancer Res. 2005 Oct 15;11(20):7434-43. doi: 10.1158/1078-0432.CCR-04-0548.
PubMed 16243817
Andre F, Mazouni C, Hortobagyi GN, Pusztai L. DNA arrays as predictors of efficacy of adjuvant/neoadjuvant chemotherapy in breast cancer patients: current data and issues on study design. Biochim Biophys Acta. 2006 Dec;1766(2):197-204. doi: 10.1016/j.bbcan.2006.08.002. Epub 2006 Aug 9.
PubMed 16962247
Apple SK, Suthar F. How do we measure a residual tumor size in histopathology (the gold standard) after neoadjuvant chemotherapy? Breast. 2006 Jun;15(3):370-6. doi: 10.1016/j.breast.2005.08.002. Epub 2005 Sep 26.
PubMed 16185870
Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.
PubMed 17438091
Eltahir A, Heys SD, Hutcheon AW, Sarkar TK, Smith I, Walker LG, Ah-See AK, Eremin O. Treatment of large and locally advanced breast cancers using neoadjuvant chemotherapy. Am J Surg. 1998 Feb;175(2):127-32. doi: 10.1016/s0002-9610(97)00279-1.
PubMed 9515529
Fernandez-Sanchez M, Gamboa-Dominguez A, Uribe N, Garcia-Ulloa AC, Flores-Estrada D, Candelaria M, Arrieta O. Clinical and pathological predictors of the response to neoadjuvant anthracycline chemotherapy in locally advanced breast cancer. Med Oncol. 2006;23(2):171-83. doi: 10.1385/MO:23:2:171.
PubMed 16720917
Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. doi: 10.1200/JCO.2005.10.517. Epub 2005 May 16.
PubMed 15897552
Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.
PubMed 9704717
Goldstein NS, Decker D, Severson D, Schell S, Vicini F, Margolis J, Dekhne NS. Molecular classification system identifies invasive breast carcinoma patients who are most likely and those who are least likely to achieve a complete pathologic response after neoadjuvant chemotherapy. Cancer. 2007 Oct 15;110(8):1687-96. doi: 10.1002/cncr.22981.
PubMed 17722109
Keam B, Im SA, Kim HJ, Oh DY, Kim JH, Lee SH, Chie EK, Han W, Kim DW, Moon WK, Kim TY, Park IA, Noh DY, Heo DS, Ha SW, Bang YJ. Prognostic impact of clinicopathologic parameters in stage II/III breast cancer treated with neoadjuvant docetaxel and doxorubicin chemotherapy: paradoxical features of the triple negative breast cancer. BMC Cancer. 2007 Nov 1;7:203. doi: 10.1186/1471-2407-7-203.
PubMed 17976237
Kuerer HM, Newman LA, Smith TL, Ames FC, Hunt KK, Dhingra K, Theriault RL, Singh G, Binkley SM, Sneige N, Buchholz TA, Ross MI, McNeese MD, Buzdar AU, Hortobagyi GN, Singletary SE. Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol. 1999 Feb;17(2):460-9. doi: 10.1200/JCO.1999.17.2.460.
PubMed 10080586
Kurosumi M. Significance and problems in evaluations of pathological responses to neoadjuvant therapy for breast cancer. Breast Cancer. 2006;13(3):254-259. doi: 10.2325/jbcs.13.254.
PubMed 16929118
Molina R, Filella X, Zanon G, Pahisa J, Alicarte J, Munoz M, Farrus B, Ballesta AM. Prospective evaluation of tumor markers (c-erbB-2 oncoprotein, CEA and CA 15.3) in patients with locoregional breast cancer. Anticancer Res. 2003 Mar-Apr;23(2A):1043-50.
PubMed 12820345
Prisack HB, Karreman C, Modlich O, Audretsch W, Danae M, Rezai M, Bojar H. Predictive biological markers for response of invasive breast cancer to anthracycline/cyclophosphamide-based primary (radio-)chemotherapy. Anticancer Res. 2005 Nov-Dec;25(6C):4615-21.
PubMed 16334152
Rouzier R, Mathieu MC, Sideris L, Youmsi E, Rajan R, Garbay JR, Andre F, Marsiglia H, Spielmann M, Delaloge S. Breast-conserving surgery after neoadjuvant anthracycline-based chemotherapy for large breast tumors. Cancer. 2004 Sep 1;101(5):918-25. doi: 10.1002/cncr.20491.
PubMed 15329898

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gene Expression Signature and Immunohistochemical Markers Associated With Response to Neoadjuvant Chemotherapy in Locally Advanced Breast Cancer
ClinicalTrials.gov ID: NCT00820690
Acronym / sponsor ID: LABC / 135/2008
Conditions: Breast Cancer
Keywords: neoadjuvant chemotherapy, advanced breast cancer, microarray, correlation analysis, oncoplastic surgery
Study type: Observational
Recruitment status: Unknown status
Enrolment: 80 participants (actual)
Lead sponsor: Barretos Cancer HospitalUniversity, hospital or other
Collaborators: University of Sao Paulo
Study start: Jul 2008
Primary completion: Apr 2012 (actual)
Study completion: Sep 2017 (estimated)
First posted: 12 Jan 2009 (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.

Detailed description

Patients will receive doxorubicin/cyclophosphamide with paclitaxel. Tumor samples collected before and after chemotherapy will be analyzed.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Clinical stage III	–	Drug: doxorubicin, Drug: cyclophosphamide, Drug: paclitaxel, Procedure: SurgeryWomen with invasive breast cancer; clinical stage III, condition to receive neoadjuvant chemotherapy based in doxorubicin/ cyclophosphamide and paclitaxel followed by surgery (mastectomy and axillary lymph node dissection)

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: women breast cancer, clinical stage III; condition to chemotherapy with doxorubicin/cyclophosphamide and paclitaxel

Key inclusion criteria (5 listed)

Women with locally advanced women breast cancer
Histology: ductal ou lobular invasive histology
Agreement to take part in the study and signature of the informed consent
Clinical condition to receive doxorubicin/cyclophosphamide and paclitaxel
ECOG 0 or I

Key exclusion criteria (6 listed)

Not clinical stage III
Inflammatory breast cancer
Previous treatment
Previous diagnosis of cancer (except basal cell or squamous cell skin carcinoma and non-invasive cervical carcinoma)
Pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
doxorubicinAlso: clinical and radiologic response4 cycles AC: doxorubicin 60mg/m2	Drug	Clinical stage III
cyclophosphamideAlso: clinical and radiologic response4 cycles AC: cyclophosphamide 600mg/m2	Drug	Clinical stage III
paclitaxelAlso: clinical, radiologic and pathologic response4 cycles T: paclitaxel 175mg/m2 after 4 AC	Drug	Clinical stage III
SurgeryAlso: Oncoplastic surgery, MastectomyThe surgery will be performed 30 days after the chemotherapy. The correlation between clinical, radiologic and pathologic response will be reported. The oncoplastic surgery rate will be reported	Procedure or surgery	Clinical stage III

Primary outcome

Clinical objective and pathological responses to chemotherapy
Time frame: 8 months
Clinical and radiological examinations to be performed before chemotherapy, after the 4 cycle of AC and before surgery. Pathologic evaluation to be performed 30 days after the last cycle of chemotherapy, i.g. after surgery.

4 secondary outcomes

Clinical, radiologic and pathologic correlation
Time frame: 3 years
Surgery
Time frame: 5 years
Overall actuarial survival
Time frame: 5 years
Pathologic complete response
Time frame: 9 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2015.
Background: PubMed 16243817Folgueira MA, Carraro DM, Brentani H, Patrao DF, Barbosa EM, Netto MM, Caldeira JR, Katayama ML, Soares FA, Oliveira CT, Reis LF, Kaiano JH, Camargo LP, Vencio RZ, Snitcovsky IM, Makdissi FB, e Silva PJ, Goes JC, Brentani MM. Gene expression profile associated with response to doxorubicin-based therapy in breast cancer. Clin Cancer Res. 2005 Oct 15;11(20):7434-43. doi: 10.1158/1078-0432.CCR-04-0548.
Background: PubMed 16962247Andre F, Mazouni C, Hortobagyi GN, Pusztai L. DNA arrays as predictors of efficacy of adjuvant/neoadjuvant chemotherapy in breast cancer patients: current data and issues on study design. Biochim Biophys Acta. 2006 Dec;1766(2):197-204. doi: 10.1016/j.bbcan.2006.08.002. Epub 2006 Aug 9.
Background: PubMed 16185870Apple SK, Suthar F. How do we measure a residual tumor size in histopathology (the gold standard) after neoadjuvant chemotherapy? Breast. 2006 Jun;15(3):370-6. doi: 10.1016/j.breast.2005.08.002. Epub 2005 Sep 26.
Background: PubMed 17438091Carey LA, Dees EC, Sawyer L, Gatti L, Moore DT, Collichio F, Ollila DW, Sartor CI, Graham ML, Perou CM. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007 Apr 15;13(8):2329-34. doi: 10.1158/1078-0432.CCR-06-1109.
Background: PubMed 9515529Eltahir A, Heys SD, Hutcheon AW, Sarkar TK, Smith I, Walker LG, Ah-See AK, Eremin O. Treatment of large and locally advanced breast cancers using neoadjuvant chemotherapy. Am J Surg. 1998 Feb;175(2):127-32. doi: 10.1016/s0002-9610(97)00279-1.
Background: PubMed 16720917Fernandez-Sanchez M, Gamboa-Dominguez A, Uribe N, Garcia-Ulloa AC, Flores-Estrada D, Candelaria M, Arrieta O. Clinical and pathological predictors of the response to neoadjuvant anthracycline chemotherapy in locally advanced breast cancer. Med Oncol. 2006;23(2):171-83. doi: 10.1385/MO:23:2:171.
Background: PubMed 15897552Mamounas EP, Bryant J, Lembersky B, Fehrenbacher L, Sedlacek SM, Fisher B, Wickerham DL, Yothers G, Soran A, Wolmark N. Paclitaxel after doxorubicin plus cyclophosphamide as adjuvant chemotherapy for node-positive breast cancer: results from NSABP B-28. J Clin Oncol. 2005 Jun 1;23(16):3686-96. doi: 10.1200/JCO.2005.10.517. Epub 2005 May 16.
Background: PubMed 9704717Fisher B, Bryant J, Wolmark N, Mamounas E, Brown A, Fisher ER, Wickerham DL, Begovic M, DeCillis A, Robidoux A, Margolese RG, Cruz AB Jr, Hoehn JL, Lees AW, Dimitrov NV, Bear HD. Effect of preoperative chemotherapy on the outcome of women with operable breast cancer. J Clin Oncol. 1998 Aug;16(8):2672-85. doi: 10.1200/JCO.1998.16.8.2672.
Background: PubMed 17722109Goldstein NS, Decker D, Severson D, Schell S, Vicini F, Margolis J, Dekhne NS. Molecular classification system identifies invasive breast carcinoma patients who are most likely and those who are least likely to achieve a complete pathologic response after neoadjuvant chemotherapy. Cancer. 2007 Oct 15;110(8):1687-96. doi: 10.1002/cncr.22981.
Background: PubMed 17976237Keam B, Im SA, Kim HJ, Oh DY, Kim JH, Lee SH, Chie EK, Han W, Kim DW, Moon WK, Kim TY, Park IA, Noh DY, Heo DS, Ha SW, Bang YJ. Prognostic impact of clinicopathologic parameters in stage II/III breast cancer treated with neoadjuvant docetaxel and doxorubicin chemotherapy: paradoxical features of the triple negative breast cancer. BMC Cancer. 2007 Nov 1;7:203. doi: 10.1186/1471-2407-7-203.
Background: PubMed 10080586Kuerer HM, Newman LA, Smith TL, Ames FC, Hunt KK, Dhingra K, Theriault RL, Singh G, Binkley SM, Sneige N, Buchholz TA, Ross MI, McNeese MD, Buzdar AU, Hortobagyi GN, Singletary SE. Clinical course of breast cancer patients with complete pathologic primary tumor and axillary lymph node response to doxorubicin-based neoadjuvant chemotherapy. J Clin Oncol. 1999 Feb;17(2):460-9. doi: 10.1200/JCO.1999.17.2.460.
Background: PubMed 16929118Kurosumi M. Significance and problems in evaluations of pathological responses to neoadjuvant therapy for breast cancer. Breast Cancer. 2006;13(3):254-259. doi: 10.2325/jbcs.13.254.

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RecruitingPhase 2
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Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
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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.

Maria Aparecida A Koike Folgueira, MD, PhD study chair

Faculdade de Medicina - Universidade de São Paulo

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.

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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. 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?

Results are not available in the source record.

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?

Clinical objective and pathological responses to chemotherapy (time frame: 8 months). 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 NCT00820690, which also lists 21 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 5 Aug 2015.