Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
Participants who have completed neo-adjuvant or adjuvant therapy with a platinum doublet and have experienced disease recurrence within months of completing the platinum doublet are eligible.
Any prior systemic therapy (e.g. adjuvant, neo-adjuvant or concurrent use of chemotherapy, immunotherapy or an investigational agent) for MCC at any time
Participant has received more than prior lines of systemic cytotoxic therapy (not including neo-adjuvant or adjuvant therapy).
Cohort B:\r\n* Must have received prior trastuzumab, pertuzumab, and T-DM in neo-adjuvant, adjuvant, or metastatic setting\r\n* No limit on prior lines of therapies
Cohort C:\r\n* Must have received prior trastuzumab, pertuzumab, and T-DM in neo-adjuvant, adjuvant, or metastatic setting\r\n* Maximum of prior lines of therapy for metastatic breast cancer\r\n* Prior treatment with fulvestrant is permitted
Patients must be newly diagnosed metastatic or must have relapsed following a prior (neo)adjuvant chemotherapy regimen. If a taxane (i.e., paclitaxel or docetaxel) was administered as part of the (neo)adjuvant regimen, PD must have occurred > months from the end of previous (neo)adjuvant treatment. For non-taxane (neo)adjuvant regimen, PD must have occurred > months from the end of previous (neo)adjuvant treatment
Participants can have no prior history of any EGFR-directed therapy, including tyrosine kinase inhibitors (TKIs) or antibodies, and must also be chemotherapy and immunotherapy naive for metastatic disease; patients who have completed adjuvant or neo-adjuvant chemotherapy > months ago are considered treatment naive
Participants can have no prior history of any EGFR-directed therapy, including tyrosine kinase inhibitors (TKIs) or antibodies, and must also be chemotherapy and immunotherapy naive; patients who have completed adjuvant or neo-adjuvant chemotherapy or immunotherapy > months ago are considered treatment naive
Plans to undergo neo-adjuvant radiation and surgery with curative intent
Prior chemotherapy:\r\n* Patients may have received - prior therapies for metastatic disease (note: for patients who have first developed recurrent/metastatic disease within months of completing any (neo)-adjuvant therapy for triple-negative breast cancer, the (neo)-adjuvant therapy is counted as a prior line of therapy)\r\n* Patients must have been off treatment with myelosuppressive chemotherapy for at least days or nonmyelosuppressive agents for days before registration; patients should also be adequately recovered (to baseline or grade ) from acute toxicities of prior treatment except for residual alopecia and peripheral neuropathy
No prior line of systemic therapy for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ? months prior to enrollment and no lingering toxicities are present.
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than months from the completion of treatment until study entry.
Pre-operative (neo-adjuvant) platinum based or other chemotherapy
Subject has had cytoreductive surgery and has completed first line platinum based chemotherapy in an adjuvant or neo-adjuvant setting as part of standard of care treatment
Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible.
Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
Patients undergoing neo-adjuvant systemic therapy.
Must be naive to systemic treatment for NSCLC. Patients who received adjuvant or neo-adjuvant chemotherapy are eligible if at least months have passed since last treatment.
Previous treatment with less than or equal to prior chemotherapy (excluding prior\n neo-adjuvant or adjuvant chemotherapy or chemoradiotherapy with curative intent)
Previous neo-adjuvant or adjuvant treatment is allowed provided that it was given >= months prior to registration
PHASE II: Previous neo-adjuvant or adjuvant treatment is allowed provided that there was no evidence of recurrent disease for at least months after completion of neo-adjuvant/adjuvant treatment
relapsed with documented evidence of progression while on (neo) adjuvant endocrine therapy or within months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease;
Patient who relapsed with documented evidence of progression more than months from completion of (neo)adjuvant endocrine therapy with no treatment for metastatic disease
All patients should have received at least one line of chemotherapy in either the advanced or neo/adjuvant setting and hormonal therapy (where appropriate); participants who have previously been treated with endocrine therapy only, and later develop triple negative disease are eligible as long as they have had one line of chemotherapy in either the advanced or neo/adjuvant setting
Completed primary treatment (surgery and radio/chemotherapy in adjuvant and/or neo-adjuvant setting) < days prior to first vaccination.
Subjects who have either received chemotherapy for metastatic disease or are considered by the treating investigator to be appropriate candidates for chemotherapy as current treatment for metastatic breast cancer are excluded. Chemotherapy administered for adjuvant/neo adjuvant disease is acceptable.
For participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least months prior to enrollment
Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
relapsed with documented evidence of relapse more than months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
relapsed with documented evidence of relapse on or within months from completion of (neo)adjuvant endocrine therapy with no treatment for advanced/metastatic disease
Have not received any prior first-line systemic therapy (prior adjuvant or neo-adjuvant therapy is permitted). Participants whose disease has progressed after > months following the last dose of systemic treatment in the adjuvant/neoadjuvant setting are eligible.
Patients who received (neo) adjuvant therapy for breast cancer are eligible
Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ? months from completion of treatment
Prior treatment with letrozole in (neo)adjuvant setting with disease-free interval ? months from completion of treatment until randomization.
Prior treatment with any anti HER-family targeted therapy in (neo)adjuvant setting.
Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ? -months from completion of treatment.
Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued > months prior to randomization.
Participant completed (neo) adjuvant taxane therapy at least months prior to randomization
Participant completed (neo) adjuvant biologic therapy at least weeks prior to randomization
Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting ? weeks prior to randomization
No prior treatment for metastatic disease (prior neo-adjuvant or adjuvant chemotherapy, except FOLFIRINOX, chemoradiation or radiation allowed)
ii) Within months of peri-operative (neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer
Patients must be treatment-nave for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with gefitinib or erlotinib as selected by the participating centre. Prior adjuvant and neo-adjuvant therapy is permitted(chemotherapy, radiotherapy, investigational agents).
Prior neo-adjuvant or adjuvant chemotherapy treatment within months prior of starting st EGFR TKI treatment
Patients previously treated with chemotherapy for mCRPC; at least months must have elapsed from chemotherapy given in the adjuvant or neo-adjuvant setting
Prior treatment with sunitinib or any other systemic therapy in the metastatic setting (prior neo/adjuvant therapy will be allowed if completed > months prior to registration and therapy not discontinued for toxicity)
Participants may or may not have received (neo) adjuvant chemotherapy, but must be at least days after last dose of chemotherapy and/or biologic therapy, with no more than grade residual toxicity at the time of screening
Prior treatment with trastuzumab and/or lapatinib or trastuzumab and pertuzumab in the neo-adjuvant or adjuvant setting is allowed but not required\r\n* Lapatininb has to be discontinued > days before the initiation of the T+P study treatments; prior lapatinib in combination with hormonal therapy for treatment of MBC is allowed but not required as long as the other eligibility criteria are met
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than months from the completion of treatment until randomization.
Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable
Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within months
Prior systemic chemotherapy for stage IIIB or IV non-small cell lung cancer. Neo-/adjuvant chemotherapy, chemoradiation or radiotherapy is permitted if at least months has elapsed prior to disease progression.
No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than months ago
Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous months
Greater than months since receiving neo-adjuvant or adjuvant chemotherapy
Any prior chemotherapy, except short-course neo-adjuvant or adjuvant chemotherapy that had been stopped for at least weeks prior to Study enrollment;
Received no more than prior chemotherapy regimen for advanced or metastatic disease (not including neo-adjuvant and/or adjuvant therapy) (Part )
Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER- adenocarcinoma of the breast (patients receiving neo/adjuvant chemotherapy eligible provided they have at least a month disease-free interval)
Patients with potential diagnosis of ovarian, fallopian, or primary peritoneal cancer; care plan including surgical debulking and traditional adjuvant or neo-adjuvant chemotherapy (- cycles of platinum and taxane based therapy)
The subject is a candidate for neo-adjuvant chemoradiation therapy
Must have completed at least cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between and years prior to registration (ongoing herceptin or other chronic human epidermal growth factor receptor [HER] directed therapies are allowed)
Patients must be deemed by their treating oncologist as candidates for (neo) adjuvant chemotherapy with dose dense doxorubicin, cyclophosphamide, and paclitaxel (ACT)
Neo-adjuvant systemic therapy
Planned to receive treatment with either adjuvant or neo-adjuvant taxane-based chemotherapy
Treatment plan that includes neo-adjuvant radiation therapy followed by surgical resection
Treatment plan that doesnt include neo-adjuvant radiation and surgical excision
Have completed primary treatment for their cancer; primary treatment will be defined as having completed all (a) definitive cancer surgery, (b) (neo)adjuvant chemotherapy, and/or (c) (neo)adjuvant radiation; breast cancer patients still receiving adjuvant endocrine or human epidermal growth factor receptor (HER) targeted therapies are eligible, as would colon cancer patients receiving a targeted agent; if there is any question whether a patient meets this eligibility requirement, Dr. Tevaarwerk (co-I, Oncology) will adjudicate
Planned (neo)adjuvant therapy with trastuzumab (Herceptin) plus chemotherapy
Completed neo-adjuvant or adjuvant chemotherapy
Have completed primary treatment defined as definitive surgery, (neo)adjuvant chemotherapy and/or (neo)adjuvant radiation; participants still receiving adjuvant endocrine or HER targeted therapies are eligible
Potential participants are women who have a diagnosis of invasive breast cancer (stage I-III) and are anticipated to start neo-adjuvant or adjuvant chemotherapy with an anthracycline and/or a taxane lasting - weeks with or without ovarian suppression
Women enrolled at Kansas University Medical Center (KUMC), should be willing to undergo brain magnetic resonance imaging (MRI) at baseline prior to starting neo-adjuvant or adjuvant chemotherapy, again just before starting the first dose of the last cycle of neo-adjuvant chemotherapy prior to scheduled surgery or weeks after the last cycle of adjuvant chemotherapy, and ~ months after completion of neo-adjuvant or adjuvant chemotherapy, unless one of the following circumstances apply: ) claustrophobia, ) medical contraindication, ) metal implants, or ) cannot be scheduled prior to scheduled start of neo-adjuvant or adjuvant chemotherapy; women will be screened by the study coordinator and staff at the Hoglund Brain Imaging Center for final eligibility to undergo fMRI (e.g., no metal implants, claustrophobia, medical contraindications); note that women declining an fMRI or in whom MRI cannot be scheduled prior to start of neo-adjuvant therapy will still be able to participate in the rest of the study but will not have a subsequent research related MRI
Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab; participants must be within their first two rounds of chemotherapy
Planned paclitaxel at a dose of mg/m^ intravenously (IV) given, in the adjuvant breast cancer (postoperative or neo-adjuvant) setting, every week for a planned course of weeks without any other concurrent cytotoxic chemotherapy (trastuzumab and/or other antibody and/or small molecule treatment is allowed, except for PARP inhibitors)
Patients who received (neo)adjuvant therapy for breast cancer are eligible. Prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease-free interval is greater than months from the completion of treatment.
Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
Participants may or may not have received (neo)adjuvant chemotherapy, but must be at least days after last dose of chemotherapy and/or biological therapy, with no more than grade residual toxicity at the time of screening
Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for weeks
Operable and necessitates adjuvant or neo-adjuvant treatment
Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both
Received any radiation or hormone therapy (neo-adjuvant, adjuvant, or salvage)
Neo-adjuvant hormonal therapy
Group A, group B and group C only: Patients not previously treated with any systemic anti-cancer therapy (e.g. cytotoxic drugs, targeted therapy, monoclonal antibody therapy including immunotherapy (e.g. PD-/PD-L inhibitors) or targeted therapies, either experimental or not), with exception of neo-adjuvant or adjuvant therapy as depicted in inclusion criterion .
Prior history of cancer, neo-adjuvant chemotherapy and radiation therapy
Neo-adjuvant hormonal therapy
Previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy
any neo-adjuvant therapy
Subjects previously treated with systemic therapies to treat cancer, such as neo-adjuvant chemotherapy or hormonal therapy.
Subjects previously treated with systemic therapies to treat cancer, such as neo-adjuvant chemotherapy or hormonal therapy.
Has been treated with (neo)adjuvant anthracycline, if they received systemic treatment in the (neo)adjuvant setting, unless anthracycline was contraindicated or not considered the best treatment option for the participant in the opinion of the treating physician.