Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Exemestane

Estrogens

Leuprolide

Goserelin

Aromatase Inhibitors

Enzyme Inhibitors

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Patients receive exemestane from week 1 to week 26 and Tucidinostat BIW from week 3 to week 26. Courses continue in the absence of disease progression or unacceptable toxicity. If the patient is premenopausal, leuprorelin or goserelin will be prescribed.

Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26

Tucidinostat

Exemestane: 25 mg QD from week 1 to week 26.

If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.

Ovarian function suppression

Ying Lin, MD

This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients and explore the genetic model which can predict neoadjuvant endocrine therapeutic results.

This study is to evaluate the efficacy of tucidinostat combined with exemestane as neoadjuvant strategy in estrogen receptor-positive early breast cancer patients.This study will recruit 30 patients. The 30 patients will receive 25 mg exemestane QD for 26 weeks. Tucidinostat will be prescribed 30 mg BIW from week 3 to week 26. During neoadjuvant treatment biopsy, CEUS and MRI will be perfomed according to protocol to evaluate the therapeutic results. Genetic testing will also be performed before and after neoadjuvant treatment to explore the predictive value. MRI evaluated ORR is primary end point. CEUS evaluated ORR, pCR, AE and RCB are secondary end point.

Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer

Neoadjuvant Tucidinostat and Exemestane in Estrogen Receptor-Positive Early Breast Cancer （NeoTEE）

ORR is defined as percentage of participants with Complete Response and Partial Response, assessed by the investigators using MRI according to the Response Evaluation Criteria in Solid Tumors (RECIST)

Contrast-enhanced ultrasound will also be performed to assess ORR

The percentage of participants with pathologically assessed ypT0 and ypTis of breast disease.

All advese effect events related with Tucidinostat and Exemestane.

Pathologilly assessed residual cancer burden according to MD Anderson protocol.

First Affiliated Hospital, Sun Yat-Sen University

Vice Director of Department of Breast Surgery

Hypoglycemic Agents

Metformin

Letrozole

Metformin HCl 500mg(morning/evening) PO daily x 1week Metformin HCl 1000mg(morning)and 500mg(evening)PO daily x 1week Metformin HCl 1000mg(morning/evening) PO daily x 22weeks

Letrozole 2.5mg PO daily + Placebo 1 tablet PO 2/day x 1week Letrozole 2.5mg PO daily + Placebo 2 tablet+ 1 tablet PO x 1 week Letrozole 2.5mg PO daily + Placebo 2 tablet PO 2/day x 22 weeks

Placebo

Wonshik Han, MD PhD

Preoperative letrozole versus letrozole with metformin in postmenopausal Estrogen receptor positive breast cancer patients

Phase II multicenter 1:1 randomized clinical trial Total 208 patients

Primary endpoint Clinical response rate

Secondary endpoint Pathologic complete response rate Breast conserving surgery rate Percent mammographic density change Ki67(%) change after 4week medication of 2nd core needle biopsy Toxicity profile of neoadjuvant letrozole, metformin

To identify the anti-tumor effect of metformin with preoperatively given letrozole in postmenopausal estrogen receptor positive breast cancer patients

Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer

Phase II Randomized Study of Neoadjuvant Metformin Plus Letrozole vs Placebo Plus Letrozole for ER-positive Postmenopausal Breast Cancer

Comparing with RECIST 1.1 From baseline to 24week(after completing medication, preoperatively)

In case that under postoperative biopsy, residual breast cancer cell is not present in primary lesion and lymph node.

IHC is performed for formalin-fixed paraffin embedded tissue at the central laboratory. Ki67 is recorded as % and percentage reduction of baseline and Ki67 expressed cell on day28 are compared.

Before pre-operative anti hormone therapy, the patients are classified into following three types

1. Candidate for BCS
2. Marginal for breast conservation surgery
3. Candidate for mastectomy only
4. Inoperable by standard mastectomy Classification of each type shall be determined by each researcher of each institution subjectively. For future separate objective analysis, central institution will collect image file of mammography of each patient.

Type of operation being actually performed in each type is compared. (BCS vs mastectomy)

Percent mammographic density (%) of cranial-caudal view of opposite breast is measured/compared based on continued variable by using validated computer-assisted thresholding program called Cumulus software (University Toronto, Toronto, Ontario, Canada).

Seoul National University Hospital

Bone Density Conservation Agents

Tamoxifen

Mitogens

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Anastrozole

Triptorelin Pamoate

Antineoplastic Agents, Hormonal

Contraceptive Agents

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3

postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3

Tamoxifen 20mg

Anastrozole 1mg

Letrozole 2.5mg

Gonadotropin Releasing Hormone (GnRH) agonist

Triptorelin

Artamonova Elena

Elena Kovalenko

Tatiana Titova

Kovalenko Elena

Titova Tatiana

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.

Nonrandomized, retrospective clincal trial

Eligible postmenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily before surgery

or

Eligible premenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily in combination with ovarian suppression before surgery

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia

Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia.

Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.

the preoperative endocrine prognostic index (PEPI)- consisting of the pathological tumor size, pathological node status, Ki67 labeling index, and ER status of residual tumors after NAE

DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.

Blokhin's Russian Cancer Research Center

Antirheumatic Agents

Docetaxel

Cyclophosphamide

Epirubicin

Six months of exemestane or anastrozole plus goserelin.

Six cycles of docetaxel plus epirubicin and cyclophosphamide(TEC).

Goserelin: 3.6mg, d1, hypodermic injection , q28d\*7 plus exemestane: 25mg, po, qd\*24w, or anastrozole: 1mg, po, qd\*24w

Neoadjuvant endocrine therapy

Docetaxel: 75mg/m2, d1, q3w\*6, Epirubicin 75mg/m2, d1, q3w\*6 and Cyclophosphamide: 500mg/m2, d1, q3w\*6

Neoadjuvant chemotherapy

Li Zhu, Prof

To compare the efficacy and safety of neoadjuvant aromatase inhibitor plus ovarian suppression with chemotherapy in premenopausal patients with hormone receptor-positive breast cancer.

Neoadjuvant therapy is nowadays the standard treatment for both early stage and locally advanced breast cancer, and exhibited similar benefit compared with adjuvant therapy in terms of disease free and overall survival. Patients achieved pathological complete response(pCR) after neoadjuvant chemotherapy have superior outcome compared with those with residual tumors in breast and/or axilla. pCR is now the most wildly accepted surrogate marker for long-term survival of patients, especially in those with triple negative or human epidermal growth factor receptor-2(HER2)-positive breast cancer. However, in luminal HER2-negative breast cancer, neoadjuvant chemotherapy is not as effective as in other subtypes of breast cancer, pCR is less noted and seems barely correlated to long-term survival benefit.

In postmenopausal patients with hormone receptor-positive breast cancer, neoadjuvant endocrine therapy of aromatase inhibitor achieved similar clinical response rate compared with neoadjuvant chemotherapy, and in premenopausal hormone receptor-positive, HER2-negative breast cancer patients, neoadjuvant aromatase inhibitor plus ovarian function suppression(OFS) has showed more pronounced efficacy than tamoxifen plus OFS.

In adjuvant setting, aromatase inhibitor combined with OFS in premenopausal patients with hormone receptor-positive breast cancer has demonstrated superior benefit in terms of disease free survival, and has been established as one of the routine options of adjuvant endocrine therapy. Notwithstanding the remarkable performance of combination of aromatase inhibitor and OFS in adjuvant therapy, the role of this treatment strategy in neoadjuvant setting has yet not been proved when compared with neoadjuvant chemotherapy.

The aim of this study is to prospectively compare the efficacy and safety of neoadjuvant aromatase inhibitor plus OFS with chemotherapy in premenopausal patients with hormone receptor-positive HER2-negative breast cancer.

Neoadjuvant Aromatase Inhibitor(AI) With Ovarian Suppression Versus Chemotherapy in Premenopausal Breast Cancer Patients

Comparison of Neoadjuvant Aromatase Inhibitors With Ovarian Suppression Versus Chemotherapy in Premenopausal Patients With Hormone Receptor-positive Breast Cancer (COMPETE): a Randomized Phase 3 Trial

Overall response rate(ORR) is defined as complete response rate plus partial response rate.

Ruijin Hospital

Professor

Carcinoma

Participants will begin treatment with Anastrozole. If not tolerated well, participants will discontinue and begin treatment using Letrozole. If not tolerated well, participants will discontinue and begin treatment using Exemestane. If not tolerated well, participants will discontinue and begin treatment on Tamoxifen.

Participants will take 1mg of anastrozole once daily, orally, for up to six cycles of 28 days.

Participants will take 2.5mg of Letrozole once daily, orally, for up to six cycles of 28 days.

Participants will take 25mg of Exemestane once daily, orally, for up to six cycles of 28 days.

Exemestane 25 mg

Participants will take 20mg of Tamoxifen once daily, orally, for up to six cycles of 28 days.

Yvonne E Taul, RN

Erin E Burke, MD

Veronica M Jones, MD

The goal of this study is to access whether treatment of early state estrogen-rich breast cancers with neoadjuvant endocrine therapy will result in higher rates of margin negativity on lumpectomy specimen.

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Phase 2 Study of Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Largest caliper measurement (millimeters) on post-therapy imaging vs. largest final size of tumor

Evaluate the effect of neoadjuvant endocrine therapy (6-months course) on margin status of breast conservation surgery for women with early stage, low-risk breast cancer, defined as ER-positive, HER2-negative, node-negative breast carcinoma (single lesion only). Negative margin status is defined as no tumor on ink.

The following parameters are required from pathologic examination in order to calculate Residual Cancer Burden (RCB) after neoadjuvant treatment: Primary tumor bed area, overall cancer cellularity (as percentage of area), percentage of cancer that is in situ disease, number of positive lymph nodes and diameter of largest metastasis. These parameters are filled in in the calculator that is available online to calculate the Residual Cancer Burden index: http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3

Pattern of response (pathologic complete response, concentric shrinking with similar cellularity, size unchanged with decreased cellularity, no treatment response)

The Breast-Q© is a patient reported outcome measure for breast surgery that measures patient reported satisfaction and quality of life (QOL) developed by Memorial Sloan Kettering Cancer Center. It is comprised of 10 scales that address: 1) psychosocial well-being, 2) sexual well-being, 3) satisfaction with breasts, 4) physical well-being, 5) adverse effects of radiation, 6) satisfaction with information - breast surgeon, 7) satisfaction with information - radiation oncologist, 8) satisfaction with surgeon, 9) satisfaction with medical team, 10) satisfaction with office staff. Each module is scored from 0-100 where higher scores reflect a better outcome.

Veronica Morgan Jones

Assistant Professor

Laila Agrawal, MD

This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.

This is a single arm feasibility study of neoadjuvant tamoxifen for locally advanced hormone receptor positive breast cancer in a low-resource setting in a middle-income country (Guatemala). Patients will be treated with tamoxifen for four to six weeks, then have an on-treatment biopsy to assess Ki-67. If Ki-67 is less than or equal to 10%, the patient will continue on tamoxifen for a total of 4 months; if Ki-67 is greater than 10% or there is clinical progression, patients will be taken off study. The study will evaluate the proportion of patients treated with four months of tamoxifen who undergo definitive surgery and the clinical and pathologic response rates.

Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country

Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor Positive Breast Cancer in a Low-Resource, Middle-Income Setting (Guatemala)

Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.

Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 \< or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)

Result is the number of participants who had Ki67 suppression (\< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.

Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes \< 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.

Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.

The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 \< or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy).

Washington University School of Medicine

Instituto National de Cancerologia, Guatemala

Vanderbilt University

Clinical Fellow

Tamoxifen 20mg by mouth daily

Tamoxifen: Tamoxifen 20mg by mouth daily

Age, Categorical

Age, Continuous

Gender

Guatemala

Region of Enrollment

Laila Agrawal

The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study.

Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility

Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen

32 of the 35 patients underwent an on-treatment biopsy; 3 patients did not follow-up and were not included in the number of participants analyzed for this measure.

Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy

This Outcome Measure was only assessed among patients undergoing surgery and is a unique outcome measure.

Overall Clinical Response Rate

This Outcome Measure was only assessed among patients who had undergone surgery.

Pathologic Complete Response

This outcome measure was analyzed in patients who were treated with 4 months of neoadjuvant tamoxifen

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Tucidinostat and Exemestane in Early Breast Cancer	NCT04465097	Breast Cancer	Tucidinostat Exemestane Ovarian functio...	18 Years -	First Affiliated Hospital, Sun Yat-Sen University
Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer	NCT01589367	Hormone Recepto...	Metformin Placebo	18 Years - 80 Years	Seoul National University Hospital
Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia	NCT05800197	Breast Cancer Neoadjuvant End...	Tamoxifen 20mg Anastrozole 1mg Letrozole 2.5mg Goserelin Triptorelin	18 Years -	Blokhin's Russian Cancer Research Center
Neoadjuvant Aromatase Inhibitor(AI) With Ovarian Suppression Versus Chemotherapy in Premenopausal Breast Cancer Patients	NCT02532400	Breast Cancer	Neoadjuvant end... Neoadjuvant che...	18 Years -	Ruijin Hospital
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer	NCT05150652	Breast Cancer HER2-negative B... Node-negative B... Breast Carcinom...	Anastrozole 1mg Letrozole 2.5mg Exemestane 25 m... Tamoxifen	18 Years - 99 Years	University of Kentucky
Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country	NCT02806544	Breast Cancer Breast Neoplasm...	Tamoxifen	18 Years -	Vanderbilt University
Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer	NCT01589367	Hormone Recepto...	Metformin Placebo	18 Years - 80 Years	Seoul National University Hospital
Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country	NCT02806544	Breast Cancer Breast Neoplasm...	Tamoxifen	18 Years -	Vanderbilt University

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