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Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment (ASTER 70s)

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ClinicalTrials.gov Identifier: NCT01564056
Recruitment Status : Active, not recruiting
First Posted : March 27, 2012
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief Summary:
The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: HORMONOTHERAPY Drug: CHEMOTHERAPY then HORMONOTHERAPY Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Systemic Treatment for Oestrogen-receptor (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment. A French UNICANCER Geriatric Oncology Group (GERICO) and Breast Group (UCBG) Multicentre Phase III Trial
Study Start Date : March 2012
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Arm A: ENDOCRINE TREATMENT
HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).
Drug: HORMONOTHERAPY

Hormonotherapy will be administered during 5 years following chemotherapy when allocated.

(Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).


Experimental: Arm B: CHEMOTHERAPY + ENDOCRINE TREATMENT

HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).

CHEMOTHERAPY regimen will be chosen amongst the following ones:

  • TC (docetaxel + cyclophosphamide)
  • AC (doxorubicin + cyclophosphamide)
  • MC (liposomal non pegylated doxorubicin [Myocet®]+ cyclophosphamide)
Drug: CHEMOTHERAPY then HORMONOTHERAPY

CHEMOTHERAPY regimen will be chosen amongst the following ones:

i) 4 cycles of TC (docetaxel + cyclophosphamide)

  • Docetaxel 75 mg/m² IV infusion at hospital every 21 days
  • Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days

ii) 4 cycles of AC (doxorubicin + cyclophosphamide)

  • Doxorubicin 60 mg/m² IV infusion at hospital every 21 days
  • Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days

iii) 4 cycles of MC (liposomal non pegylated doxorubicin [Myocet®]+ cyclophosphamide)

  • Myocet® 60 mg/m² IV infusion at hospital every 21 days
  • Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days

HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II).





Primary Outcome Measures :
  1. Overall survival [ Time Frame: Median follow-up = 4 years ]
    The OS is defined as the interval between the date of randomization and the date of death from any cause.


Secondary Outcome Measures :
  1. Specific overall survival [ Time Frame: median follow-up = 4 years ]
    The specific OS is defined as the interval between the date of randomization and the date of death due to cancer. Alive patients or dead patients from another cause will be censored at the last follow-up

  2. Disease-free survival (DFS) [ Time Frame: median follow-up = 4 years ]
    The DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first.

  3. Event-free survival (ESF) [ Time Frame: median follow-up = 4 years ]
    The EFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first.

  4. Toxicity [ Time Frame: on-treatment period (defined as the period from the time of first dose of study medications up to 30 days of the last dose) ]
    The severity of the adverse events and toxicities will be graded according the NCI CTCAE scale version 4.0.

  5. Geriatric Assessment [ Time Frame: at the end of the chemotherapy in arm B or 16 weeks after the randomization in arm A (endocrine treatment only), and then each year during a 4-year follow-up period, for both arms ]
    the geriatric questionnaires (CCI & listing comedications, G8, IADL or MMSE) will be completed by a geriatrician or a person trained to geriatric assessment before randomization, at the end of the chemotherapy in arm B or 16 weeks after the randomization in arm A (endocrine treatment only), and then each year during a 4-year follow-up period, for both arms.

  6. Four-Year Mortality Index for Older Adults(Lee Score) [ Time Frame: At the inclusion ]
    A 4-year mortality score including items depicting functional status, nutritional status and comorbidities, three key issues in elderly, will be systematically calculated.

  7. Quality of life [ Time Frame: before randomization, at the end of the chemotherapy in arm B or 16 weeks after randomization in arm A, and then each year during a 4-year follow-up period ]
    Quality of life (QoL) questionnaires (QLQ C30 and QLQ-ELD15) will be completed by the patients before randomization, at the end of the chemotherapy in arm B or 16 weeks after randomization in arm A, and then each year during a 4-year follow-up period, for both arms of the group I. In case of premature end of treatment, a final Questionnary will be completed.

  8. Usefulness of GG by RT-PCR [ Time Frame: two weeks after surgery (local histo. and GG test) then after inclusions are performed (central histo.) ]
    The prognostic signature of the GG test will be evaluated in an elderly population by comparison to standardized routine histopathological criteria and to the results obtained in the general non elderly population. In the whole cohort (n=2000) results of the GG will be compared to routine histopathological characteristics (pN, histological grade, mitotic count, Ki67 index, determination of Elston and Ellis histological grade) as determined locally or centrally for assessment of patient prognosis.

  9. Cost-effectiveness analysis [ Time Frame: at the end of the chemotherapy in arm B or 16 weeks after randomization in arm A, and then each year during a 4-year follow-up period, for both arms of the group I. ]
    In parallel with efficacy analysis, measured by an objective clinical result indicator of state of health, such as the number of year gained (overall survival), costs for the two treatment strategies (endocrine treatment only or endocrine treatment and chemotherapy) in adjuvant systematic treatment will be also estimated. This study should provide information for decision-makers about the incremental efficacy obtained in relation to the incremental cost.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged ≥ 70 yo,
  • Histologically proven invasive breast cancer (regardless of the type),
  • Complete surgery performed before enrolment: radical modified mastectomy or breast conservative surgery, with either a sentinel lymph node procedure or axillary lymph node dissection,
  • Any N status (pN+ or pN0),
  • No clinically or radiologically detectable metastases (M0),
  • Oestrogen receptor (ER)-positive, as defined by a ≥ 10% tumor stained cells by immunohistochemistry (IHC),
  • HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative),
  • Normal haematological function: ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin > 9 g/dl,
  • Normal hepatic function: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN; alkaline phosphatases ≤ 3 ULN,
  • Creatinine clearance (MDRD formula) ≥ 40 mL/min,
  • PS (ECOG) ≤ 2,
  • Patient able to comply with the protocol,
  • Patients must have signed a written informed consent form prior to any study specific procedures, including the agreement for the use of archived tumoral material for genomic screening and data collection,
  • Patients must be affiliated to a Social Health Insurance.

Exclusion Criteria:

  • Any metastatic impairment, including homolateral sub-clavicular node involvement, regardless of its type,
  • Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
  • ER-negative breast cancer (i.e. <10% tumor stained cells by IHC),
  • HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive,
  • Any chemotherapy, hormonal therapy or radiotherapy for breast cancer before surgery,
  • PS (ECOG) ≥ 3,
  • Any specific contra-indication to the study drugs (including but not limited to hypersensitivity to the study drugs or their components),
  • Patient deprived of freedom or under tutelage,
  • Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564056


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Sponsors and Collaborators
UNICANCER
Investigators
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Principal Investigator: Etienne Brain Institut Curie, Saint Cloud

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT01564056     History of Changes
Other Study ID Numbers: GERICO11/PACS10
2011-004744-22 ( EudraCT Number )
UC-0103/1102 ( Other Identifier: UNICANCER )
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Keywords provided by UNICANCER:
Adjuvant systemic treatment
Breast cancer
Elderly patients
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tamoxifen
Cyclophosphamide
Doxorubicin
Aromatase Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Steroid Synthesis Inhibitors