Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
Patients must have completed all chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. chemotherapy planned to be given after surgery); patients must have completed at least cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes\r\n* Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of cycles of neoadjuvant chemotherapy is administered; more than cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist
Patients with HER- positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER- therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial
All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy\r\n* Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact eligibility
No more than weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy
No neoadjuvant radiation therapy
No SLN surgery/excisional biopsy for pathological confirmation of axillary status prior to or during neoadjuvant chemotherapy
Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant therapy regimen\r\n* NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll\r\n* NOTE: Patients that were not able to complete their planned neoadjuvant chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate as long as no further systemic standard of care therapy is planned by the treating physician
No neoadjuvant chemotherapy =< weeks before pre-registration
Patients with HER-positive tumors must have received neoadjuvant anti-HER therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
Patients must have had neoadjuvant chemotherapy followed by surgery; the recommended neoadjuvant treatment should include - weeks of a third generation chemotherapy regimen as recommended by National Comprehensive Cancer Network (NCCN) guidelines for triple negative breast cancer (examples include dose dense adriamycin-cytoxan [AC] followed by dose-dense paclitaxel; weekly paclitaxel x followed or preceded by cyclophosphamide-adriamycin-fluorouracil [FAC], fluorouracil-epirubicin-cytoxan [FEC], AC or dose dense AC; docetaxel either followed or preceded by FEC/FAC or AC; carboplatin-containing neoadjuvant chemotherapy is also allowed); patients who cannot complete all planned treatment cycles for any reason are considered high risk and therefore are eligible for the study if they have residual disease; patients must have resolution of adverse event(s) of the most recent prior chemotherapy to grade or less, except alopecia and =< grade neuropathy which are allowed
Patient must have received at least two cycles of triplet neoadjuvant therapy (all three drugs) during step
Patient must be registered to step no less than days and no more than days after the end of their final cycle of neoadjuvant therapy
One of the breast disease stages listed below:\r\n* Note: In the definitions below, definitive surgery is defined as the final surgery performed to obtain clear surgical margins\r\n* Neoadjuvant chemotherapy was not administered\r\n** If neoadjuvant chemotherapy was NOT administered, pathologic staging must be T-, N-a following definitive surgery\r\n* Neoadjuvant chemotherapy was administered\r\n** If prior to initiation of neoadjuvant chemotherapy clinical staging was T-, N, pathologic staging must be T-, N-a following definitive surgery\r\n** If prior to initiation of neoadjuvant chemotherapy clinical staging was T-, N, pathologic staging must be T-, N-a following definitive surgery\r\n** If prior to initiation of neoadjuvant chemotherapy there was cytologic or pathologic confirmation of axillary nodal involvement (per any of the criteria listed below), pathologic staging must be T-, N-a following definitive surgery\r\n*** Positive fine-needle aspiration (FNA) (ie, demonstrating malignant cells)\r\n*** Positive core needle biopsy (ie, demonstrating invasive adenocarcinoma)\r\n*** Positive sentinel lymph node biopsy (ie, demonstrating invasive adenocarcinoma)
Candidate for neoadjuvant chemotherapy
Patient Received neoadjuvant chemoradiation (- weeks prior to surgery)
Subjects with MIBC not meeting the above criteria are still eligible provided the patient declines neoadjuvant cisplatin-based chemotherapy, after specific informed consent describing the known benefits of cisplatin-based chemotherapy
Patients undergoing primary medical treatment (hormone or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumor size
INCLUSION - TREATMENT: Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and plan for completion of one year of trastuzumab
Plans for administration of neoadjuvant chemotherapy or hormonal therapy
Eligible for neoadjuvant chemotherapy
For patients with pancreatic cancer:\r\n* Stage I-III cytologically or histologically-proven pancreatic adenocarcinoma\r\n* Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection\r\n* Patients may have prior neoadjuvant chemotherapy, but no neoadjuvant chemoradiation\r\n* No cancer chemotherapy treatment weeks prior to day of treatment
Patients with biopsy proven dedifferentiated chondrosarcoma that chose not to pursue neoadjuvant chemotherapy
Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or surgery
Subjects must not have received or plan to receive neoadjuvant chemotherapy either before radiotherapy or before surgery
Chemotherapy is planned for the patient in the neoadjuvant setting
Received neoadjuvant chemotherapy
Plan for neoadjuvant chemoradiation
PRE-SCREENING: Must have had at least one and not more than two prior chemotherapy regimens for advanced disease (neoadjuvant chemotherapy would not be counted as a line of therapy)
A female patient who is a woman of child-bearing potential (WCBP) and a male patient with a partner who is a WCBP must agree to use a medically accepted method for preventing pregnancy for the duration of immunotherapy and neoadjuvant chemotherapy and until after completion of breast surgery or, for patients who do not receive neoadjuvant chemotherapy, for a minimum of months following the last dose of pembrolizumab
Prior treatment with neoadjuvant therapy
NEOADJUVANT COHORT
Consideration for neoadjuvant therapy
Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy
A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after complete cycles of treatment
No prior therapy for current breast cancer and not planning neoadjuvant chemotherapy
Contraindication to repeat breast biopsy (neoadjuvant chemotherapy group)
Patients who have received any non-anti-folate containing neoadjuvant or systemic chemotherapy are eligible; any prior intravesical therapy, or immunotherapy is allowed
Patients must have an intact evaluable primary tumor or biopsy proven axillary node involvement with at least . centimeter (cm) smallest dimension based on imaging after neoadjuvant anthracycline-based chemotherapy and prior to initiation of neoadjuvant chemotherapy under this protocol; baseline measurements and evaluations must be obtained within weeks of registration to the study; all areas of disease should be recorded in order to assess response and uniformity of response to therapy
Neoadjuvant chemotherapy
Patients who were exposed to neoadjuvant chemotherapy or chemotherapy after prostatectomy
Received chemotherapy, radiotherapy, or biologic therapy within the last days (neoadjuvant chemotherapy excluded)
Received chemotherapy, radiotherapy, or biologic therapy within the last days (neoadjuvant chemotherapy excluded)
Prior or planned neoadjuvant systemic therapy for breast cancer
Neoadjuvant chemotherapy will be permitted prior to the initiation of SBRT radiation therapy on this clinical trial; there must be a minimum of weeks between the completion of any neoadjuvant chemotherapy and the beginning of SBRT radiation therapy; furthermore, restaging must be done prior to registration to ensure that patients remain resectable
Patients who will receive neoadjuvant chemotherapy are not eligible
Patients treated with neoadjuvant chemotherapy are not eligible
Neoadjuvant chemotherapy for current malignancy
EXCLUSION CRITERIA FOR REGISTRATION: subjects receiving neoadjuvant chemotherapy for whom interval debulking surgery (assuming adequate response to therapy) is not planned
Other than the cycles of neoadjuvant chemotherapy and surgery (mentioned above), must not have received other treatment for their gastric cancer.
Patient has at least one of the following:\r\n* Pathologic N-\r\n* Pathologic T\r\n* Neoadjuvant chemotherapy and did not achieve pathologic response at time of surgery
Have had an R/R resection of PDA following neoadjuvant chemotherapy
Any cytotoxic treatments, such as neoadjuvant chemotherapy, planned before subsequent surgical procedure
Patients must have completed a surgical debulking procedure, or be candidates for neoadjuvant chemotherapy
Patients must have received neoadjuvant chemotherapy of at least weeks. This period must include weeks of a taxane -containing neoadjuvant therapy (Exception: For patients with progressive disease that occurred after at least weeks of taxane-containing neoadjuvant treatment, a total treatment period of less than weeks is also eligible).
NEOADJUVANT COHORT
Prior neoadjuvant FOLFIRINOX
Undergone neoadjuvant chemotherapy
Neoadjuvant chemotherapy
Any neoadjuvant chemotherapy
Patients who have received neoadjuvant chemotherapy or neoadjuvant hormonal therapy for the current cancer
Neoadjuvant radiation therapy or chemotherapy for cervical cancer
Complete pathologic response to neoadjuvant chemotherapy (NAC).
Patients must not have received neoadjuvant chemotherapy for the present disease
Undergoing concurrent neoadjuvant therapies for breast cancer
Completed all planned therapy for T >= . cm, Nx, M or Tx, N >= N, M triple negative breast cancer (TNBC) (American Joint Committee on Cancer, th edition) meeting the following guidelines:\r\n* Received neoadjuvant chemotherapy and/or completed adjuvant chemotherapy with or without radiation; (the patient may have had adjuvant and/or neoadjuvant chemotherapy for their disease); patients who received neoadjuvant chemotherapy may have either residual disease or a complete response; adjuvant/neoadjuvant chemotherapy regimens must include at least cycles of a standard chemotherapy regimen, and generally this should include one of the generally accepted standard regimens (including but not limited to: doxorubicin hydrochloride, cyclophosphamide and paclitaxel [AC-T], Taxotere and cyclophosphamide [TC], doxorubicin hydrochloride and cyclophosphamide [AC], or cyclophosphamide, methotrexate and fluorouracil [CMF]); for patients who received their standard chemotherapy as part of a clinical trial, the regimen should include at least cycles of therapy; patients who initiate planned chemotherapy but discontinue before receiving cycles due to toxicity will be eligible\r\n* All planned radiation therapy and surgery for the treatment of the current cancer should be complete (not including plastic or reconstructive surgery)\r\n* Patients with local-regional recurrence without evidence of distant metastases (no definite stage IV disease) who are treated with curative intent may be eligible following completion of all surgery and/or chemotherapy and/or radiotherapy; such patients must have no evidence of residual disease by standard clinical and radiological examination (per investigator discretion) following completion of curative intent treatment
Prior non-cisplatin based neoadjuvant systemic chemotherapy for urothelial carcinoma (prior intravesical chemotherapy or immunotherapy is permissible)
Prior cisplatin based neoadjuvant systemic chemotherapy for more than cycles
Women undergoing neoadjuvant chemotherapy are not eligible
Be undergoing open, or minimally invasive LAR for the treatment of a rectal or rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be treated with or without neoadjuvant therapy. Long-course neoadjuvant therapy must have been completed ? weeks prior to LAR surgery (Day ).
For subjects receiving neoadjuvant therapy only, time between start of neoadjuvant treatment and randomization must be ? weeks and subjects must be scheduled to undergo definitive treatment (including surgery and/or radiotherapy) with curative intent within approximately months of starting neoadjuvant treatment
Patient who received neoadjuvant chemotherapy for ovarian cancer
Patients with muscle invasive bladder cancer (MIBC) must have never received and currently be ineligible for cisplatin-based neoadjuvant chemotherapy due to any of the following:\r\n* Calculated creatinine clearance of < ml/min\r\n* Karnofsky performance status (KPS) < \r\n* Solitary kidney or\r\n* Patient refusal to undergo neoadjuvant chemotherapy
Neoadjuvant chemotherapy if relapse occurred at least months after surgical resection;
If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)
Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within weeks before the planned surgery.
Patients who will receive neoadjuvant therapy prior to definitive surgery
The subject is not a candidate for neoadjuvant chemoradiation therapy (i.e., patients with borderline resectable pancreatic ductal adenocarcinoma who are known to benefit from neoadjuvant treatment regimens)
Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs
Planned neoadjuvant systemic therapy
Subject with neoadjuvant chemotherapy or chemoradiation
Scheduled for neoadjuvant chemotherapy and/or chemoradiation for pancreatic cancer
A disposition to neoadjuvant chemotherapy with planned interval tumor reductive surgery after complete cycles of treatment
Neoadjuvant chemotherapy or radiation therapy
Undergoing induction or neoadjuvant chemotherapy prior to radiotherapy
Women who are planned to receive neoadjuvant therapy
Patient did not undergo either placement of a preoperative biliary stent/drain or neoadjuvant chemotherapy with or without radiation therapy
Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery
Patient must be able to undergo stereotactic-vacuum-assisted breast biopsy with clip placement after completion of neoadjuvant chemotherapy
Patients with HER-positive tumors must have received neoadjuvant anti-HER therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
Patients treated with neoadjuvant hormonal therapy only are not eligible
Patients who did not undergo trimodality imaging after completion of neoadjuvant chemotherapy (breast ultrasound, MRI, and mammography)
Patients receiving neoadjuvant chemotherapy or recently completed neoadjuvant chemotherapy and will undergo surgery within weeks are eligible
Participants must be candidates for neoadjuvant therapy (NAT) upfront
Prescribed neoadjuvant chemotherapy for breast cancer
Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy
Women undergoing neoadjuvant chemotherapy
Patients will be treated with neoadjuvant chemoradiotherapy for this condition
Received neoadjuvant chemotherapy prior to surgical resection
Any systemic neoadjuvant (or preoperative) therapy between the core biopsy and lumpectomy
Participants who are candidates for neoadjuvant chemotherapy or neoadjuvant endocrine therapy for the treatment of newly diagnosed, invasive breast cancer
Have biopsy-proven breast cancer and decided to receive neoadjuvant chemotherapy
Patients must have a known site of disease; please note, for patients undergoing neoadjuvant therapy, this requirement must be met retrospectively prior to the start of neoadjuvant therapy; patients who are in radiological/clinical remission after neoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligible
Use of neoadjuvant hormonal manipulation
Be scheduled for neoadjuvant chemotherapy
Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
Will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist
Receiving neoadjuvant chemotherapy
Neoadjuvant chemoradiation prior to resection is planned
Patients with biopsy-proven breast cancer and biopsy-proven axillary lymph node metastases at Beth Israel Deaconess Medical Center (BIDMC) who are candidates for neoadjuvant chemotherapy or neoadjuvant endocrine therapy
Neoadjuvant chemotherapy
Candidate for neoadjuvant chemotherapy
No neoadjuvant endocrine therapy or chemotherapy within months