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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_692 | Other Identifier | Merck Registration Number |
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This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy in participants with breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | 18F-FLT-PET imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FLT-PET/CT Imaging | Radiation | Participants receive the investigational radiotracer 18F-FLT intravenously and undergo Positron Emission Tomography (PET)/Computed Tomography (CT) scans at the following three times: prior to initiation of chemotherapy, at the end of the first cycle of treatment, and at the conclusion of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy. | Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest. | Baseline and up to 3 weeks |
| Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy. | Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of tissue radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmax measures the maximum radioactivity values within a region of interest. | Baseline and up to 3 weeks |
| Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy. | Core needle biopsies (CNB) are obtained after completing imaging studies at baseline and approximately 2 to 3 weeks later, after the first cycle of chemotherapy. These tissue samples are then used to measure expression of the cell proliferation marker Ki-67, by manually counting percentage positive immunostained cells, denoted the labeling index (LI). | Baseline and up to 3 weeks |
| Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy. | Core needle biopsies (CNBs) obtained at baseline and after approximately 2-3 weeks of treatment, at the end of the first cycle of chemotherapy, are used to measure cell proliferation by a Proliferation Signature Score (PSS). PSS is calculated from the messenger RNA (mRNA) expression of 47 genes that negatively correlate with time to recurrence, and involves taking their average normalized scores. For reference, a database of 16,000 tumors gave a minimum PSS of 1.51 and a maximum PSS of 2.89; where a higher PSS is associated with an increase in proliferation, higher tumor grade and worse outcomes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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After enrollment, 2 of the 46 participants discontinued due to lack of available 3'-deoxy-3'[18F]-fluorothymidine (18-FLT), leaving 44 participants as the baseline population.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy. | Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmean averages the radioactivity values within a region of interest. | Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy | Posted | Mean | Standard Deviation | SUV | Baseline and up to 3 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. |
| Baseline and up to 3 weeks |
| Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Baseline and up to 3 weeks |
| Baseline and up to 3 weeks |
| Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | MRI of participants was used to measure tumor volumes at baseline and after completing chemotherapy, after approximately 11 to 30 weeks of treatment. | Baseline and up to 30 weeks |
| Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Baseline and up to 30 weeks |
| Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Baseline and up to 30 weeks |
| Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Baseline and up to 30 weeks |
| Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Baseline and up to 30 weeks |
| Other Protocol Specified Criteria |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy. | Core needle biopsies (CNBs) obtained at baseline and after approximately 2-3 weeks of treatment, at the end of the first cycle of chemotherapy, are used to measure cell proliferation by a Proliferation Signature Score (PSS). PSS is calculated from the messenger RNA (mRNA) expression of 47 genes that negatively correlate with time to recurrence, and involves taking their average normalized scores. For reference, a database of 16,000 tumors gave a minimum PSS of 1.51 and a maximum PSS of 2.89; where a higher PSS is associated with an increase in proliferation, higher tumor grade and worse outcomes. | Participants who had PSS determined at Baseline and after 1 cycle of chemotherapy | Posted | Mean | Standard Deviation | Proliferation Score | Baseline and up to 3 weeks |
|
|
|
|
| Secondary | Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | MRI of participants was used to measure tumor volumes at baseline and after completing chemotherapy, after approximately 11 to 30 weeks of treatment. | Participants who had tumors measured by MRI at Baseline and at the end of chemotherapy | Posted | Mean | Standard Deviation | cm^3 | Baseline and up to 30 weeks |
|
|
|
| Secondary | Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Participants who had their PSS measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy | Posted | Number | 90% Confidence Interval | Correlation coefficient | Baseline and up to 30 weeks |
|
|
|
| Secondary | Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Participants who had their Ki-67 LI measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy | Posted | Number | 90% Confidence Interval | Correlation coefficient | Baseline and up to 30 weeks |
|
|
|
| Primary | Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy. | Participants undergo a baseline 18F-FLT-PET/CT scan followed by a magnetic resonance imaging (MRI) scan prior to chemotherapy. These scans are repeated in approximately 2 to 3 weeks, at the end of the first cycle of chemotherapy to derive a standardized uptake value (SUV) of 18F-FLT, which is calculated from the ratio of tissue radioactivity concentration within a region of interest, and the injected dose at the time of injection, divided by body weight. The SUVmax measures the maximum radioactivity values within a region of interest. | Participants whose SUV were measured at Baseline and after 1 cycle of chemotherapy | Posted | Mean | Standard Deviation | SUV | Baseline and up to 3 weeks |
|
|
|
| Primary | Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy. | Core needle biopsies (CNB) are obtained after completing imaging studies at baseline and approximately 2 to 3 weeks later, after the first cycle of chemotherapy. These tissue samples are then used to measure expression of the cell proliferation marker Ki-67, by manually counting percentage positive immunostained cells, denoted the labeling index (LI). | Participants whose Ki-67 Labeling Index were measured at Baseline and after 1 cycle of chemotherapy | Posted | Mean | Standard Deviation | Labeling Index | Baseline and up to 3 weeks |
|
|
|
| Primary | Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Participants who had both their changes from baseline in Ki-67 LI and SUVmean determined at the end of Cycle 1 of chemotherapy. | Posted | Number | 90% Confidence Interval | Correlation coefficient | Baseline and up to 3 weeks |
|
|
|
| Primary | Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Participants who had both their changes from baseline in Ki-67 LI and SUVmax determined at the end of Cycle 1 of chemotherapy. | Posted | Number | 90% Confidence Interval | Correlation coefficient | Baseline and up to 3 weeks |
|
|
|
| Secondary | Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Participants who had their SUVmax measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy | Posted | Number | 90% Confidence Interval | Correlation coefficient | Baseline and up to 30 weeks |
|
|
|
| Secondary | Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy. | The Spearman's rank correlation coefficient was computed by ranking the data and using the ranks in the Pearson product-moment correlation formula. In case of ties, the averaged ranks were used. | Participants who had their SUVmean measured after 1 cycle of chemotherapy and their tumors measured at the end of chemotherapy | Posted | Number | 90% Confidence Interval | Correlation coefficient | Baseline and up to 30 weeks |
|
|
|
| 8 |
| 44 |
| 39 |
| 44 |
| Rectal bleeding | Gastrointestinal disorders |
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| Chest pain | General disorders |
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| Fever | General disorders |
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| Catheter site infection | Infections and infestations |
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| Neutrophil count decreased | Investigations |
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| Dizziness | Nervous system disorders |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders |
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| Neutropenia | Blood and lymphatic system disorders |
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| Constipation | Gastrointestinal disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Haemorrhoids | Gastrointestinal disorders |
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| Heartburn | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Stomatitis | Gastrointestinal disorders |
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| Fatigue | General disorders |
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| Fever | General disorders |
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| Mucositis | General disorders |
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| Oedema | General disorders |
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| Weakness generalised | General disorders |
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| Hypersensitivity reaction | Immune system disorders |
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| Common cold | Infections and infestations |
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| Incision site pain | Injury, poisoning and procedural complications |
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| Alanine aminotransferase increased | Investigations |
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| Haemoglobin decreased | Investigations |
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| Anorexia | Metabolism and nutrition disorders |
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| Bone pain | Musculoskeletal and connective tissue disorders |
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| Myalgia | Musculoskeletal and connective tissue disorders |
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| Dizziness | Nervous system disorders |
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| Headache | Nervous system disorders |
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| Neuropathy | Nervous system disorders |
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| Insomnia | Psychiatric disorders |
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| Breast pain | Reproductive system and breast disorders |
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| Postmenopausal symptoms | Reproductive system and breast disorders |
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| Cough | Respiratory, thoracic and mediastinal disorders |
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| Sore throat | Respiratory, thoracic and mediastinal disorders |
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| Alopecia | Skin and subcutaneous tissue disorders |
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| Nail changes | Skin and subcutaneous tissue disorders |
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| Rash | Skin and subcutaneous tissue disorders |
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| Dyspepsia | Gastrointestinal disorders |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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