Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Estrogens

Jeffrey Vacirca, MD

This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors. This study also examines the impact of the test results on patients' reported outcomes, including their decisional conflict status and anxiety levels.

The primary objective of this study is to assess the extent to which the Prosigna test results affect the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early stage breast cancer conventionally considered candidates for genomic testing based on current treatment guidelines. The oncologist's initial recommendations will be based on the utilization of tools or algorithms based on clinical and pathologic factors. No genomic tools will be used in the initial assessment. Changes in recommendation after availability of Prosigna test results will include (1) hormonal therapy alone or (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the test.

Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients

A Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients Who Are Candidates for Genomic Testing

NanoString Technologies, Inc.

Carcinoma

Adenocarcinoma

Antineoplastic Agents

Antirheumatic Agents

Anti-Inflammatory Agents

Anti-Infective Agents

Docetaxel

Bevacizumab

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Triamcinolone

Triamcinolone Acetonide

Triamcinolone hexacetonide

Triamcinolone diacetate

Lenograstim

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

docetaxel, doxorubicin, cyclophosphamide, and pegfilgrastim/filgrastim

docetaxel, cyclophosphamide, and bevacizumab

bevacizumab 15 mg/kg IV every 21 days for 6 cycles followed by bevacizumab 15 mg/kg IV every 21 days until 1 year following the first dose of bevacizumab

bevacizumab

docetaxel 75 mg/m2 IV every 21 days for 6 cycles

docetaxel

doxorubicin 50 mg/m2 IV every 21 days for 6 cycles

doxorubicin

Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles

Group 2 and 3: cyclophosphamide 600 mg/m2 IV every 21 days for 6 cycles

cyclophosphamide

pegfilgrastim 6 mg subcutaneous (SC) Day 2 every 21 days for 6 cycles \[filgrastim (Neupogen®) 5 mcg/kg Days 2-10 may be given in lieu of pegfilgrastim (Neulasta®), but pegfilgrastim is preferred.\]

pegfilgrastim

Norman Wolmark, MD

The main purpose of this study is to learn if adding bevacizumab to standard treatment with chemotherapy (docetaxel, doxorubicin, and cyclophosphamide) for early stage HER2-negative breast cancer will prevent breast cancer from returning. A second purpose of this study is to learn if adding bevacizumab to treatment with chemotherapy will help women with HER2-negative breast cancer live longer. The researchers also want to learn about the side effects of the combination of drugs used in this study.

The B-46-I/07132 study, a multicenter, open-label, randomized Phase III, adjuvant therapy trial, will compare the value of adding bevacizumab to a non-anthracycline-based chemotherapy regimen relative to the same chemotherapy without bevacizumab and relative to an anthracycline-based chemotherapy regimen in women with resected node-positive or high-risk node-negative, HER2-negative breast cancer. This trial will determine whether the addition of bevacizumab to a regimen of docetaxel and cyclophosphamide (TCB) improves invasive disease-free survival relative to docetaxel and cyclophosphamide alone (TC). A secondary aim will be to determine whether the addition of bevacizumab to TC improves invasive disease-free survival compared to a regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC). Other secondary aims include whether TCB improves disease-free survival, overall survival, and recurrence-free interval relative to TC alone and to TAC. The toxicities of the three regimens will also be compared.

Patients in the B-46-I/07132 study will be randomized to one of three treatment regimens: Group 1 patients will receive 6 cycles of TAC administered every 21 days (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, and cyclophosphamide 500 mg/m2); Group 2 patients will receive 6 cycles of TC administered every 21 days (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2); and Group 3 patients will receive 6 cycles of TCB every 21 days with bevacizumab therapy continuing every 21 days after completion of chemotherapy until 1 year following the first dose (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2, and bevacizumab 15 mg/kg). Primary prophylaxis with pegfilgrastim or filgrastim is required for Group 1 patients (optional for patients in Groups 2 and 3). Patients will also receive adjuvant radiation therapy as clinically indicated and endocrine therapy for hormone receptor-positive tumors.

Tumor samples will be submitted for correlative science studies to evaluate predictors of study therapy benefit. Submission of a tumor sample is a study requirement for all patients.

A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

A Phase III Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

Genentech, Inc.

US Oncology Research

NSABP Foundation Inc

Miguel Martin, M.D., Ph.D.

The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the Prosigna test.

A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay

Prospective Observational Study to Evaluate the Impact of the Determination of the Intrinsic Subtypes of Breast Cancer by PAM50 NanoString Technology in the Use of Adjuvant Chemotherapy in Women With Breast Cancer, HR+ and Node -.

Cedar Associates LLC

Illumina, Inc.

Grupo Espanol de Investigacion del Cancer de Mama

Spanish Breast Cancer Research Group

Hospital General Universitario Gregorio Marañon

Vall d'Hebron Institute of Oncology

Mouth and Tooth Diseases

Rare Diseases

Carcinoma, Squamous Cell

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Coagulants

Methylene Blue

Tolonium Chloride

All patients have undergone completion neck dissection following SNB in the process of standardization. The SNB was localized by peritumoral infiltration of the nano colloid, followed by dynamic planar imaging for 30 minutes, and then SPECT was performed. The surgery was performed on the same day within 6 hours of localisation, and intraoperatively, either methylene blue or indocyanine green was used as an adjunct. Appropriately labelled sentinel nodes were assessed on the frozen section, which was then sectioned into 2-3mm slices perpendicular to the longest axis of the node and submitted entirely for microscopic evaluation. A minimum of 2 sections were evaluated, one stained with Toluidine blue and the other with rapid Haematoxylin and Eosin (HE) stain. The nodes were subsequently subjected to histopathological processing.

All patients have undergone completion neck dissection following SNB in the process of standardization.

Sentinel node biopsy

Richa Vaish, MS, M.Ch

Richa Vaish, MS. M.Ch

Sentinel node biopsy is a suitable alternative to END and is recommended in standard guidelines. Investigators have been doing SNB in their department to standardize the process for the last two years. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at their institute.

Elective neck dissection (END) is the standard of care in node-negative early oral cancers.

However, it is associated with morbidity predominantly of shoulder dysfunction. Moreover, nearly 55-70% are true node-negative and are over-treated with this approach. Attempts have been made to overcome this limitation and to identify true node-negative patients. Sentinel node biopsy has shown the highest diagnostic accuracy among all other options. The SN is the first echelon node that drains directly through the lymphatics from the primary tumour. The principle of SNB is based on the fact that since it is the first echelon node, it would be the first site of regional metastasis. Therefore, the metastasis is unlikely to involve other nodal levels if the SNB is negative. It is the standard of care in breast cancers and melanoma. The concept made its way into oral cavity tumours and has been explored for over a decade in this setting. The results of the multi-institutional trial by Civantos et al. reported a high NPV of 94% of this procedure in early oral cancers that were node negative. Since then, various meta-analyses have shown that SNB has a high NPV making it a strong diagnostic modality. Schilling et al. reported the 3-year results of SNB in oral cancers in a multicentric study comprising 415 patients. The authors successfully identified the SN in 99.5% of cases and reported an FNR of 14%, which was high. Despite this, the study showed a high 3-year-disease-specific survival of 94%. Recently published Phase III Randomized controlled trials have shown that the overall survival of sentinel node biopsy is comparable to END with lesser morbidity in shoulder dysfunction. The advantage of the procedure is that only 25-30% of the patients who are SNB positive need to undergo neck dissection, and it spares unnecessary neck clearance and hence limits the morbidity in the remaining 70-75% of cases. SNB is a suitable alternative to END and is recommended in standard guidelines. However, SNB has a learning curve, it is recommended that the process be standardized, and the team should perform adequate SNB, followed by the completion of neck dissection before sparing the neck based on SNB. Investigators have been doing SNB in their department to standardize the process following the publication of level I evidence. This study aims to analyze the diagnostic accuracy of the SNB performed to standardize the procedure at the investigator's institute.

Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience

Sensitivity, specificity, negative predictive value, positive predictive value, False negative rate, SNB identification rate

Level-wise frequency of SN metastasis, Frequency of metastasis in the SN basin, Frequency of metastasis to extra sentinel nodal basin

Tata Memorial Hospital

Professor

Post mastectomy radiotherapy will be given

Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks

Post Mastectomy Radiation therapy

Tabassum Wadasadawala, MBBS,MD,DNB

Anil K Anand, MBBS,MD

Ritesh Kumar, MBBS, MD

Yogesh Anap, MBBS,MD,DNB

Nidhi Patni, MBBS,MD

Nidhi Patni, MBBS, MD

Budhi S Yadav, MBBS,MD

Vineeta Goel, MBBS, DNB

Vineeta Goel, MBBS,DNB

Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed low risk of recurrence in this population as a whole. However, in the setting of multiple adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of recurrence documented for patients with one to three positive lymph nodes. Numerous retrospective series have reported the outcome and patterns of failure for post-mastectomy patients treated without radiation. Many of these series have analyzed several high risk factors which were predictive of loco-regional recurrence wherein the role of adjuvant post-mastectomy radiation can be considered. Some authors have used combinations of prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and lympho-vascular space invasion to define subgroups with more specific risks of loco-regional recurrence than single factors alone. The current trial hypothesizes that "Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free survival" and propose to address the question in randomized setting.

Arm Experimental Post Mastectomy Radiotherapy Arm No Intervention: No Post Mastectomy Radiotherapy

Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer

Post-Mastectomy Radiation Therapy in High Risk, Node Negative Women With Early Breast Cancer (PMRT-NNBC)

This will be measured using Kaplan Meier time to event analysis

This is the incidence of local recurrence in the chest wall

This is the incidence of recurrence in the regional lymphatics

Quality of life will be assesses by EORTC QLQ C-30 core questionnaire and the breast cancer specific module BR-23 questionnaire

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients	NCT02625935	Breast Cancer		-	NanoString Technologies, Inc.
A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer	NCT00887536	Breast Cancer	bevacizumab docetaxel doxorubicin cyclophosphamid... pegfilgrastim	18 Years - 70 Years	NSABP Foundation Inc
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay	NCT01899079	Breast Cancer		-	NanoString Technologies, Inc.
Sentinel Node Biopsy in Early Oral Cancers a Tertiary Cancer Centre Experience	NCT05950737	Oral Cavity Squ...	Sentinel node b...	18 Years - 75 Years	Tata Memorial Hospital
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients	NCT02625935	Breast Cancer		-	NanoString Technologies, Inc.
A Clinical Trial Comparing the Combination of TC Plus Bevacizumab to TC Alone and to TAC for Women With Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer	NCT00887536	Breast Cancer	bevacizumab docetaxel doxorubicin cyclophosphamid... pegfilgrastim	18 Years - 70 Years	NSABP Foundation Inc
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients	NCT02625935	Breast Cancer		-	NanoString Technologies, Inc.
Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer	NCT02992574	Breastcancer	Post Mastectomy...	18 Years - 80 Years	Tata Memorial Centre
A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay	NCT01899079	Breast Cancer		-	NanoString Technologies, Inc.
Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer	NCT02992574	Breastcancer	Post Mastectomy...	18 Years - 80 Years	Tata Memorial Centre

Spots Global Cancer Trial Database for node negative