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| ID | Type | Description | Link |
|---|---|---|---|
| ML30001 | Other Identifier | Genentech, Inc. |
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This is a prospective, single-arm, phase II study of 32 evaluable patients treated with NEOADjuvant Aromatase inhibitor and Pertuzumab/Trastuzumab (NEOADAPT) without chemotherapy for hormone receptor positive (HR+), [i.e. Estrogen Receptor positive (ER+) and/or Progesterone Receptor positive (PR+)] HER2+ localized, non-metastatic stage I - IIb breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant Biological Therapy | Experimental | Subjects will receive an aromatase inhibitor for the duration of the study [exemestane (tablet, oral, 25 mg/day), letrozole (tablet, oral, 2.5 mg/day) or anastrozole (tablet, oral, 1 mg/day)]. Premenopausal subjects will receive leuprolide acetate (11.25 mg, intramuscular injection, 3-month intervals). Pertuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 840 mg, infused over 60-90 minutes; subsequent cycles: 420 mg, infused over 30-60 minutes). Trastuzumab will be given by intravenous infusion in 3-week cycles until disease progression (Cycle 1 Day 0: 8 mg/kg, infused over 60-90 minutes; subsequent cycles: 6 mg/kg, infused over 30-60 minutes) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | Drug | Aromatase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Pathological Response | The presence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. Pathological complete response (pCR) is defined as the absence of residual invasive cancer. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Treatment | Median number of days between Day 0 (first treatment of trastuzumab and pertuzumab) and three weeks after the last dose of neoadjuvant trastuzumab and pertuzumab on treatment protocol. | One year |
| Evidence of Radiographic Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Ahn, MD | Midwestern Regional Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southeastern Regional Medical Center | Newnan | Georgia | 30265 | United States | ||
| Cancer Treatment Centers of America at Midwestern Regional Medical Center |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2017 | Jul 23, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| D016729 | Leuprolide |
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Letrozole | Drug | Aromatase inhibitor |
|
|
| Anastrozole | Drug | Aromatase inhibitor |
|
|
| Leuprolide Acetate | Drug | Luteinizing Hormone-Releasing Hormone agonist |
|
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| Pertuzumab | Drug | Monoclonal antibody (HER2/neu receptor antagonist) |
|
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| Trastuzumab | Drug | Monoclonal antibody (HER2/neu receptor antagonist) |
|
|
Change in dimensions (millimeters) of target lesions (along long axis) and non-target lesions (along long axis for non-lymphatic lesions and short axis for lymph nodes) as observed by Magnetic Resonance Imaging and quantified by modified RECIST 1.1 criteria. |
| Assessed every 12 weeks up to one year |
| Measurement of Left Ventricular Ejection Fraction (LVEF) | Determination of cardiac function as measured by echocardiogram or multi-gated acquisition scan (MUGA). | Assessed every 12 weeks up to one year |
| Mammaprint Genomic Analysis | Mammaprint will estimate the risk level of the subject's tumor. | One year or up to 3 months after definitive surgery |
| Zion |
| Illinois |
| 60099 |
| United States |
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |